Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KSEA UNIMAT PLUS (K963949)KARL STORZ Endoscopy-America, Inc.1996-12-19
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT (K964828)S.C. Johnson & Son, Inc.1996-12-19
MICADENT (K964059)Hampton Research1996-12-19
PHILIPS COMPUTED RADIOGRAPHY (K964124)Philips Medical Systems, Inc.1996-12-18
STREPTOCOCCUS MIC PANEL (K963641)Dade Microscan, Inc.1996-12-18
QLVA PLUS (K963859)Sanders Data Systems, LLC1996-12-18
QUINIDINE ENZYME IMMUNOASSAY (K964212)Diagnostic Reagents, Inc.1996-12-18
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA (K964459)Universal Reagents, Inc.1996-12-18
LINX NETWORKING SYSTEM (K964250)Sterling Diagnostic Imaging, Inc.1996-12-18
IMIG-MRI (K963953)Imig-Mri Systems, LLC1996-12-18
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964442)Bayer Corp.1996-12-18
FILM SCANNER 300 (K960839)Cannon U.S.A., Inc.1996-12-18
C-ARM TABLE IVS-100 (K963888)Shimadzu Medical Systems1996-12-18
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (K962864)Alko Diagnostic Corp.1996-12-18
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (K964072)ETHICON, Inc.1996-12-18
MOBILE CT PROSPEED FAMILY (K963896)GE Medical Systems1996-12-18
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT (K962049)Polymedco, Inc.1996-12-18
SYNERMED DIRECT BILIRUBIN REAGENT KIT (K963939)Synermed, Inc.1996-12-18
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM (K963826)Endocare, Inc.1996-12-18
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE (K963861)Dejarnette Research Systems1996-12-18
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA (K964270)Universal Reagents, Inc.1996-12-18
CAT SCOOTER WITH DS60 VONYTOLLRT (K962583)Invacare Respiratory Corp.1996-12-18
REPLIDERM WOUND DRESSING (K963228)Orphan Medical, Inc.1996-12-18
TOMTEC ECHO-SCAN (K963807)Tomtec Imaging Systems, Inc.1996-12-18
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-18
PIPERACILLIN/TAZOBACTAM 4 (K964203)Ab Biodisk1996-12-18
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) (K962538)C.R. Bard, Inc.1996-12-17
PLASTIC SUNGLASSES (K964316)Medical Reports Exchange, Inc.1996-12-17
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (K963993)Rusch, Inc.1996-12-17
SCIMED CHOICE PT VISION PTCA GUIDE WIRE (K962572)Scimed Life Systems, Inc.1996-12-17
PERSONAL TELEMEDICINE MODULE (K964554)American Telecare, Inc.1996-12-17
1ST RESPONSE DISPOSABLE MANOMETER (K961318)Intertech Resources, Inc.1996-12-17
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM (K962894)Synthes (Usa)1996-12-17
SURGIFLATOR-20 PIM (K955791)W.O.M. World of Medicine GmbH1996-12-17
EYE FIXATION SPECULUM (K964289)Eyefix, Inc.1996-12-17
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS (K962185)CooperVision, Inc.1996-12-17
HYDRO-SELECT GUIDEWIRE (K954642)Microvena Corp.1996-12-17
GDC PATIENT RETURN ELECTTRODE MODEL 45021 (K963307)Target Therapeutics1996-12-17
HIGH PRESSURE INJECTION LINES (K963749)Maxxim Medical1996-12-17
CELSITE PORT WITH PRECONNECTED CATHETER (K962230)B.Braun Medical, Inc.1996-12-16
EEG ELECTRODES (K962283)Teca, Inc.1996-12-16
HEART NEBULIZER #100609 (K963910)Vortran Medical Technology 1, Inc.1996-12-16
ELECSYS FSH ASSAY (K964693)Boehringer Mannheim Corp.1996-12-16
MULTIDEX HYDROPHILIC WOUND DRESSING GEL (K962917)Lange Medical Products, Inc.1996-12-16
N LATEX CRP MONO REAGENT (K964687)Behring Diagnostics, Inc.1996-12-16
COVERAGE SPRAY HBV (K964835)Convatec, A Division of E.R. Squibb & Sons1996-12-16
SOLDER 615 (K964708)Gateway Alloys, Inc.1996-12-16
ELECSYS CALCHECK FSH (K964829)Boehringer Mannheim Corp.1996-12-16
SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 (K963884)Somnus Medical Technologies, Inc.1996-12-16
DEPUY CANNULATED CROSS PIN SCREW SYSTEM (K963973)Depuy, Inc.1996-12-16
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. (K963747)Whitehill Manufacturing, Inc.1996-12-16
VENTNET; CENTRAL MONITORING STATION (K963633)Puritan Bennett Corp.1996-12-16
SOLDER 585 (K964707)Gateway Alloys, Inc.1996-12-16
LITHOVAC SUCTION/ASPIRATION PROBE (K964111)Electro Medical Systems SA1996-12-16
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED (K964345)ETHICON, Inc.1996-12-16
SOLDER GPW (K964713)Gateway Alloys, Inc.1996-12-16
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (K963296)Incstar Corp.1996-12-16
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 (K964100)Vision-Sciences, Inc.1996-12-16
SOLDER 650 (K964706)Gateway Alloys, Inc.1996-12-16
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) (K964558)Johnson & Johnson Clinical Diagnostics, Inc.1996-12-16
STREPTOLEX-STAT (K962296)Unipath , Ltd.1996-12-16
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (K963297)Incstar Corp.1996-12-16
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER (K962641)Medtronic Vascular1996-12-16
ELECSYS FT3 (K963127)Boehringer Mannheim Corp.1996-12-16
MODEL 430-07 ENDOCARDIAL PACING LEAD (K954610)Intermedics, Inc.1996-12-16
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL (K964323)Fen Dental Mfg., Inc.1996-12-16
ISLAND BIOSURGICAL BOLSTER (K960101)Island Biosurgical, Inc.1996-12-16
SIGMA DIAGNOSTICS WASH CONCENTRATE (K963539)Sigma Diagnostics, Inc.1996-12-16
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 (K963934)Bio-Rad Laboratories, Inc.1996-12-16
SOLDER GPY (K964705)Gateway Alloys, Inc.1996-12-16
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER (K963094)Cynosure, Inc.1996-12-16
ADVANTAGE MAPF HIP FEMORAL COMPONENT (K960643)Biomet, Inc.1996-12-16
NOVUS STANDARD AND PEDIATRIC VALVES (K961859)Integra Neurocare, LLC1996-12-16
ELECSYS CALCHECK LH (K964830)Boehringer Mannheim Corp.1996-12-16
ACROMED CABLE/WIRE PEDICLE SCREW (K964007)Acromed Corp.1996-12-16
THERATEST EL-RFSCR (K962050)Theratest Laboratories, Inc.1996-12-16
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE (K964328)Synthes (Usa)1996-12-13
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ (K964173)Richard Wolf Medical Instruments Corp.1996-12-13
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 (K963062)Beckman Instruments, Inc.1996-12-13
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT (K964535)S.C. Johnson & Son, Inc.1996-12-13
ONTRAK TESTCUP 5 (MODIFICATION) (K964355)Roche Diagnostic Systems, Inc.1996-12-13
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT (K964613)S.C. Johnson & Son, Inc.1996-12-13
EVITA 4 (K961687)Drager, Inc.1996-12-13
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 (K964640)Canyon Diagnostics, Inc.1996-12-13
COVERAGE HBV (K964749)Convatec, A Division of E.R. Squibb & Sons1996-12-13
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT (K964415)Kamiya Technology Services1996-12-13
MANAN D BAG (K963849)Manan Medical Products, Inc.1996-12-13
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET (K964418)Kamiya Technology Services1996-12-13
PROC APC ASSAY, PROC CONTROL PLASMA (K962968)Behring Diagnostics, Inc.1996-12-13
JEL-40 (CODE NAME RD-0430) (K964158)Jelenko Co.1996-12-13
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964068)Bayer Corp.1996-12-13
NICCHECK I (K963733)Dynagen, Inc.1996-12-13
KARL STORZ FRIMBERGER VARIOGUIDE (K962212)KARL STORZ Endoscopy-America, Inc.1996-12-13
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) (K963707)Nellcor Puritan Bennett, Inc.1996-12-13
TRIAD II DISINFECTANT CLEANER AND DEODORANT (K964610)S.C. Johnson & Son, Inc.1996-12-13
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS (K963728)China Chongqing Bashan Instrument Factory1996-12-12
ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR (K964071)Oratec Interventions, Inc.1996-12-12
LI'S ITCH STOPPER (K963824)Hontech Foundation For Medical Technology1996-12-12
DIGIFOCUS ITE (K964683)Oticon, Inc.1996-12-12
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) (K963806)Bmw Medical, Inc.1996-12-12
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Every clearance here is in the API, with alerts when new ones post.