Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
POWDER FREE EXAMINATION GLOVES (K932550)Unigloves , Ltd.1994-09-19
RX90 FEMORAL COMPONENT (K942028)Biomet, Inc.1994-09-19
SYNERGY QUAD (K941443)Remel Co.1994-09-19
MICRO X-80 HF (K944149)Fischer Imaging Corp.1994-09-16
CORDIS STEERABLE GUIDEWIRE (K943340)Cordis Corp.1994-09-16
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. (K931902)Valleylab, Inc.1994-09-16
BARD URINE COLLECTION PRODUCTS MODIFICATION (K940206)C.R. Bard, Inc.1994-09-16
END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM (K943927)American Hydro-Surgical Instruments, Inc.1994-09-16
EPISTAT-II NASAL CATHETER (K943718)Merocel Corp.1994-09-16
3M 1154 LASER IMAGER (K936142)3M Information,Imaging and Electronic Sector1994-09-16
ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION (K935617)Davol Inc., Sub. C. R. Bard, Inc.1994-09-16
STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM (K924685)Leibinger GmbH1994-09-16
MICRO X-50 HF (K944147)Fischer Imaging Corp.1994-09-16
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX (K934987)Elscint, Inc.1994-09-16
OLYMPIC BILI-LITE (K940996)Olympic Medical Corp.1994-09-16
MICROLINE SCREEN FOR AMPHETAMINE (K935052)Drug Screening Systems, Inc.1994-09-16
THE BLENDTONE ROYALE (K943398)Instantron1994-09-16
PROSHIELD PLUS MULTIPLE GLOVES (K943735)Sino (U.S.A.) Co.1994-09-16
THE ELITE SPECTRUM (K943396)Instantron1994-09-16
MICRO X-30HF (K944148)Fischer Imaging Corp.1994-09-16
LOWER BODY CYCLES (K935061)Biodex Medical Systems, Inc.1994-09-16
STABILET (K942904)Hill-Rom, Inc.1994-09-16
KARL STORZ LASER ACCESSORIES (K942786)KARL STORZ Endoscopy-America, Inc.1994-09-16
CEQUAL-QUANTITATIVE ANALYSIS (K942363)Nuccardiac Software, Inc.1994-09-16
DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM (K933454)L&H Airco1994-09-16
ALL-IN-THE-EAR (K943318)Golden State Audiology Assoc.1994-09-16
INTERACOUSTICS CLINICAL AUDIOMETER (K941920)Precision Acoustics Ind., Inc.1994-09-16
VISIONLINK DICOM MODULE (K942860)Evergreen Technologies, Inc.1994-09-16
SOPHOS DENTAL DIAMOND (K943841)Sophos Technologic1994-09-16
MODEL #310T03500 WRIST COIL (K942355)Medic, Inc.1994-09-16
COLLAR BUTTON VENTURI VENT TUBE (K943848)Micromed Development Corp.1994-09-16
MICRO X-65 HF (K944150)Fischer Imaging Corp.1994-09-16
DOSER (K935955)Newmed Corp.1994-09-16
UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (K935520)Biodex Medical Systems, Inc.1994-09-16
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH (K935277)KARL STORZ Endoscopy-America, Inc.1994-09-16
MT-300 CASSETTE HOLDER (K941600)Medtec, Inc.1994-09-16
THE SS-99 (K943399)Instantron1994-09-16
INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER (K941273)Innovasive Devices, Inc.1994-09-16
SEMI-RECUMBENT CYCLES (K935216)Biodex Medical Systems, Inc.1994-09-16
PHILIPS THORAVISION (K931071)Philips Medical Systems, Inc.1994-09-15
PROPORTIONAL SOLENOID VALVE (K922102)Puritan Bennett Corp.1994-09-15
IOLAB LACRIMAL DUCT CATHETER (K935233)Chiron Vision Corp.1994-09-15
PORTLAND TROCARS (K943786)Mikroland Micromecanique1994-09-14
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT (K943754)Bionostics, Inc.1994-09-14
NIDA-5/RT, DRUG OF ABUSE CONTROLS (K942041)Meditech1994-09-14
MAMMOMAT 300 AND MAMMOMAT 3000 (K932672)Siemens Medical Solutions USA, Inc.1994-09-14
LIPASE CALIBRATOR (K943704)The DU Pont Co.1994-09-14
SURGIMAT (K926259)W.O.M. World of Medicine GmbH1994-09-14
SUNGLASSES (K943562)Australian Optical Co., Inc.1994-09-14
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (K942009)Primus Corp.1994-09-14
IV START KITS (K943047)Sterile Concepts, Inc.1994-09-14
SPECTACLE FRAME (K943561)Australian Optical Co., Inc.1994-09-14
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (K941807)Intersect Systems, Inc.1994-09-14
BILIRUBIN PLUS/PEDIATRIC CONTROLS (K943290)Medi-Tech, Inc.1994-09-14
TROCARS,CANNULAE,SHEATHS,OBTURATORS (K943697)Karl Storz Endoskop GmbH1994-09-14
SUNGLASSES (K940421)Double Hero Corp.1994-09-14
MONOJECT LUER ADAPTER (K940961)Sherwood Medical Co.1994-09-14
SUNGLASS CLIP (K943640)Australian Optical Co., Inc.1994-09-14
MIRAGE EYEWEAR INC. (K944026)Mirage Eyewear, Inc.1994-09-14
NIL (K943963)Max-Vision (H.K.)Limited1994-09-14
MOBILETT PLUS MOBILE X-RAY SYSTEM (K932106)Siemens Medical Solutions USA, Inc.1994-09-14
VIP PLUS PERCUTANEOUS INTRODUCER (K944107)Medamicus, Inc.1994-09-14
NIL (K944108)Micron Metal & Plastic Manufactory Co.1994-09-14
LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE (K931077)J.K. Chemicals, Ltd.1994-09-14
SPECTACLE FRAME (K943641)Australian Optical Co., Inc.1994-09-14
ILO MADE IN ITALY; GARBO HAND FINISHED ITALY (K943296)Ilo Industria Lombarda Ottica Srl1994-09-14
OPERA SYSTEM (K943376)Miles, Inc.1994-09-14
DOA-PLUS, DRUGS OF ABUSE CONTROLS (K942257)Medical Diagnostic Technologies, Inc.1994-09-14
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) (K941860)Helena Laboratories1994-09-14
SPECTACLE FRAMES (K943792)Kt Optique, Inc.1994-09-14
SWABZYME OXIDASE (K934130)E-Y Laboratories, Inc.1994-09-14
NIL (K944109)Keep Top Intl., Ltd.1994-09-14
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION (K940231)Datascope Corp.1994-09-13
DAB WELDLESS WHEELCHAIR (K944122)Da Intl. , Ltd.1994-09-13
INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES (K940731)Innervision, Inc.1994-09-13
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME (K944194)Med-Tek Innovations, Inc.1994-09-13
GABRIS LAPAROSCOPIC SURGICAL KITS (K944104)Gabris Surgical Corp.1994-09-13
ASLAN DUAL ACTION JAWS GRASPING FORCEPS (K944082)Aslan Medical Technologies, Ltd.1994-09-13
TRANSPARENT DRESSING (K943111)Acutek Adhesive Specialties, Inc.1994-09-12
PASSPORT (K941853)Boston Scientific Corp1994-09-12
HEMODIALYSIS BATH (K922990)Medi-Tech, Inc.1994-09-12
TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS (K933108)Landos, Inc.1994-09-12
GC SURFLEX F (K943388)GC America, Inc.1994-09-12
LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (K944103)Gabris Surgical Corp.1994-09-12
HAIG NAIL (K940736)Howmedica Corp.1994-09-12
KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE (K935279)KARL STORZ Endoscopy-America, Inc.1994-09-12
LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (K943989)Gabris Surgical Corp.1994-09-12
QMS THEOPHYLLINE CS (K942991)Seradyn, Inc.1994-09-09
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (K942552)Medi-Tech, Inc.1994-09-09
URINE REAGENT STRIP-3 PARAMETERS (K940469)Teco Diagnostics1994-09-09
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182)Oral-B Laboratories1994-09-09
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER (K943485)Sherwood Medical Co.1994-09-09
TNT TROPONIN T (K942632)Streck Laboratories, Inc.1994-09-09
PROPOXPHENE EIA TEST (K943414)Diagnostic Reagents, Inc.1994-09-09
THIXOFLEX (K935896)Zhermack Dental Production1994-09-09
FASCOUNT SYSTME (K933486)Becton Dickinson Immunocytometry Systems1994-09-09
E-VAC-U-ACCESSORIES (K942520)Bull Frog Mfg. Co.1994-09-09
MICRO-TOUCH LATEX MEDICAL GLOVES (K943620)Johnson & Johnson Medical, Inc.1994-09-09
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 (K940679)Helena Laboratories1994-09-09
PLASMINOGEN RID TEST KIT (K941346)The Binding Site, Ltd.1994-09-09
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Every clearance here is in the API, with alerts when new ones post.