Atlas FDA

1982

3,408 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CARCINO-CEK (K823353)Biologics Intl., Inc.1982-12-14
MODEL 640 LINEAR SCANNER (K827176)Ge Medical Systems Information Technologies1982-12-14
ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER (K828586)Cranbury Medical Labs, Inc.1982-12-14
YSI MODEL 23L LACTATE ANALYZER (K822812)Yellow Springs Instrument Co., Inc.1982-12-13
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) (K822681)Amico Lab, Inc.1982-12-13
UROCOMP REMOTE CONTROL 1804 (K822916)Life-Tech Intl., Inc.1982-12-13
MINISTIM 180 (K822924)Micron Instruments, Inc.1982-12-13
THE PROGRESSIVE CHAIR (K823277)Progressive Productions , Ltd.1982-12-13
MONOCLONAL ANTIBODY T4 RADIO-KIT (K823265)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-12-09
CENTRAL VENOUS CATHETER (K823351)Plasmedics, Inc.1982-12-09
BIRT-A-PAD #730 (K823492)Birtcher Corp.1982-12-09
PRISMA C-REACTIVE PROTEIN ASSAY (K823416)Syva Co.1982-12-09
EBV IGM TEST (K822734)Gull Laboratories, Inc.1982-12-09
NON-REUSABLE UNIVERSAL NEBULIZER FILTE (K823257)Ohio Medical Products1982-12-09
KOAGULAB 40-A AUTOMATED COAGULATION SYS (K823131)Ortho Diagnostic Systems, Inc.1982-12-09
AIRWAY TEMPERATURE SENSOR (K821505)Mon-A-Therm, Inc.1982-12-09
OXYGEN MONITOR IL 408 (K823374)Instrumentation Laboratory CO1982-12-09
KM-KAL L3 (K823044)Kmn Products, Inc.1982-12-09
PRISMA-C-REACTIVE PROTEIN CALIBRATORS (K823417)Syva Co.1982-12-09
DSL 1600 (K822898)Diagnostic Systems Laboratories, Inc.1982-12-09
RESPIRATORY CIRCUIT ADAPTOR (K823287)Thoratec Laboratories Corp.1982-12-09
MCGEE 26GA. SUCTION TUBE (K823437)Treace Medical, Inc.1982-12-09
PRISMA C-REACTIVE PROTEIN CONTROLS (K823415)Syva Co.1982-12-09
NASAL CANNULA (K823506)Seven Harvest Intl. Import & Export1982-12-09
CHOLESTEROL CHOD-PAP TEST (K823302)Boehringer Mannheim Corp.1982-12-09
DOSOMETRIC RELEASE STERILIZATION (K823058)Stan-Pak Ent.1982-12-09
INNOTRON FLUORIMETER SERIES ONE-10 (K822942)Innotron of Oregon, Inc.1982-12-09
STAINLESS STEEL PISTONS (K823483)Humboldt Products1982-12-09
HEARING AID HB-33 RIONET (K823383)Kindel & Anderson1982-12-09
MICROSURGICAL GAUGE (K823436)Treace Medical, Inc.1982-12-09
HEARING AID HB-72 RIONET (K823384)Kindel & Anderson1982-12-09
MYSTIK AUTOCLAVE TAPE (K823208)Mystik Corp.1982-12-09
ECHO-PULSE KM555 (K821736)Rabar, Inc.1982-12-09
PORTABLE SHOWER BATH (K823327)Wall Manufacturer, Inc.1982-12-07
ELECTROENCEPHALOGRAPH (K823140)Nihon Kohden America, Inc.1982-12-07
DERM-A-TEC SKIN BARRIER FILM (K822713)Professional Medical Products, Inc.1982-12-07
BE#1000-INSTANT ON/OFF O2 VALVE (K823408)Instrumentation Industries, Inc.1982-12-07
NEUROTRAC (K823116)Interspec, Inc.1982-12-07
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY (K823231)Yellow Springs Instrument Co., Inc.1982-12-07
ELECTROSURGICAL UNIT (K823083)Kelleher Corp.1982-12-07
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP (K823232)Yellow Springs Instrument Co., Inc.1982-12-07
UNI-TIP COLOSTOMY IRRIGATION CONE (K823274)Howmedica Corp.1982-12-07
NEPHROSS, ANDANTE H.F. (K823375)Organon Teknika Corp.1982-12-07
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY (K822867)Isolab, Inc.1982-12-03
ANTIBODY TO MUMPS VIRUS IFA TEST (K822826)Electro-Nucleonics Laboratories, Inc.1982-12-03
SIGMA REAGENT SYSTEM NO. 885 (K822733)Sigma Chemical Co.1982-12-03
FISCH MODIFIED TOTAL OSSICULAR PROSTHES (K823442)Treace Medical, Inc.1982-12-03
BLOOD GAS EXPER. SYSTEM 8700 (K822778)Exper Corp., Inc.1982-12-03
MYCAREL AGAR MYCOBROTIC AGAR (K823308)Troy Biologicals, Inc.1982-12-03
METAL KNEE & HIP PROSTHESIS (K823051)Zimmer, Inc.1982-12-03
FISCH MODIFIED TEF-WIRE PISTON (K823429)Treace Medical, Inc.1982-12-03
HERPES TRANSETTE (K823443)Spectrum Diagnostic, Inc.1982-12-03
SCHAEDLER AGARS (K823248)Granite Diagnostics, Inc.1982-12-03
MYCOTRIUM-RS (K822737)Hana Biologics, Inc.1982-12-03
AUTOPAK FERRITIN TEST DELIVERY SYS (K823275)Micromedic Systems1982-12-03
HEYER-SCHUTE UNIVERSAL URETERAL STENT (K823418)American Hospital Supply Corp.1982-12-03
CAP-RIA 16 (K823240)Capintec, Inc.1982-12-03
BIPOLAR COAGULATOR #9620/9621 (K823184)Concept, Inc.1982-12-03
NATURALYTE BICARBONATE DIALYSATE 4400 (K823115)Erika, Inc.1982-12-03
OCTAPETTES (K823137)Corning Costar Corp.1982-12-03
LIQUIZYME CALCIUM REAGENT SET (K823219)American Research Products Co.1982-12-03
MCGEE MODIFIED STAINLESS STEEL PISTON (K823440)Treace Medical, Inc.1982-12-03
STAX FINGER SPLINTS (K823393)Orthopedic Systems, Inc.1982-12-03
SURE SNIP (K823485)South Mountain Medical1982-12-03
IMPLANTABLE PACING LEAD, TINED #3262 & (K823447)Vascular Products, Inc.1982-12-03
FLUSHING SOLUTION (K823283)Nobel Scientific Industries, Inc.1982-12-03
STERILE WATER SYSTEM (K823230)Syntex Dental Products, Inc.1982-12-03
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K (K822682)Amico Lab, Inc.1982-12-03
MYCOTRIUM-GU (K822736)Hana Biologics, Inc.1982-12-03
WALKING HEEL (K823394)Orthopedic Systems, Inc.1982-12-03
MODELS G6H, G6T, G1H & G1T (K823460)Widex Hearing Aid Co., Inc.1982-12-03
ELASTIC COMPRESSION ANKLET (K823350)Podiatry Products Corp.1982-12-03
EBV-M KIT (K822985)Litton Bionetics1982-12-03
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE (K823441)Treace Medical, Inc.1982-12-03
READY-BOX BODY-TEMP MEDIA WARMER MALLIN- (K823356)Forma Scientific, Inc.1982-12-03
KINETIC MOTION BED (K823095)Motion Manufacturers, Inc.1982-12-03
IMPLANTABLE PACING LEAD TINED #3390 & (K823448)Oscor, Inc.1982-12-03
SURGICAL LIGHT (K823360)Amsco Co.1982-12-03
TRACTION-STEEL FRAMING SYSTEM (K823395)Orthopedic Systems, Inc.1982-12-03
LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (K823122)Granite Diagnostics, Inc.1982-12-03
CERA 8 (K823377)Cer-Met, Inc.1982-12-03
MODEL H 37E (K823468)Marcon Hearing Instruments, Inc.1982-12-03
CALMSET 3 TM (K823146)Thought Technology , Ltd.1982-12-03
CERA COLOR (K823378)Cer-Met, Inc.1982-12-03
PRODUCTS IMPLANTABLE PACING LEAD,TINED (K823446)Oscor, Inc.1982-12-03
MICROPAD (K823301)Fia Man Co.1982-12-03
HEARING AID #G6H & G6T (K823431)Widex Hearing Aid Co., Inc.1982-12-03
GASTRIC LAVAGE KIT (K823195)Autovage1982-12-03
1424 TUMISTORE (K822914)Life-Tech Intl., Inc.1982-12-03
ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370)Syva Co.1982-12-03
AGAR P (K823102)Dms Laboratories1982-12-03
IRRIGATION SET (K822560)Utah Medical Products, Inc.1982-12-03
MARTIN & LEMIS AGAR W/VCAT INHIBITOR (K823309)Troy Biologicals, Inc.1982-12-03
SMITH'S MEDIUM (K823139)Granite Diagnostics, Inc.1982-12-03
CAUSSE TEF-PISTON (K823439)Treace Medical, Inc.1982-12-03
OCTAGONAL ALUMINUM FRAMING SYSTEM (K823372)Orthopedic Systems, Inc.1982-12-03
CADIO-RESPIRATORY MONITOR #CR-2 (K823312)Electromed Intl., Ltd.1982-11-30
MIKRO-TIP CATHETER PRESSURE TRANSDUCER (K823434)Millar Instruments, Inc.1982-11-30
MEDTRONIC MODELS 4011 & 4511 (K822781)Medtronic Vascular1982-11-30
RIGHT ATRIAL CATHETER (K822964)Quinton, Inc.1982-11-30
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Every clearance here is in the API, with alerts when new ones post.