Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ADS-GEL AND INSULATING-GEL (K915355)Heraeus Kulzer, Inc.1992-01-31
LACERATION TRAY (K914929)Westmark Hospital Supplies1992-01-31
DERMAPROOF (K914840)Pharmalett Medical Care, Holland B.V.1992-01-31
DRESSING CHANGE KIT (K914927)Westmark Hospital Supplies1992-01-31
AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE (K915489)United States Surgical, A Division of Tyco Healthc1992-01-31
PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD (K915111)Metalor Dental USA Corp.1992-01-31
HEMOPLUS (K913622)Sarstedt, Inc.1992-01-31
GOLDLENS(TM) (K913239)Doran Instruments, Inc.1992-01-31
MODEL H170 PEDIATRIC CHEST X-RAY UNIT (K915667)H.L. Lyons Co.1992-01-31
SR-IVOCAP PLUS (K915377)Ivoclar North America, Inc.1992-01-31
MITEK SNAP PAK(TM), MODIFICATION (K915081)Mitek Surgical Products, Inc.1992-01-31
COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (K915299)Cogan Corp.1992-01-31
CARRINGTON WOUND DRESSING 4X4(TM) (K915001)Carrington Laboratories, Inc.1992-01-31
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS (K915240)Intermedics Orthopedics1992-01-31
INSTRUMENT WIPE AND CORNEAL SHIELD (K912576)Katena Products, Inc.1992-01-31
D-DIMER WELLCOTEST (HA10) (K915203)Wellcome Diagnostics1992-01-31
ASRA, SCREENING AUDIOMETER (K914232)Mercury Electronics (Scot) , Ltd.1992-01-31
HOWMEDICA ALUMINA FEMORAL HEAD (K915184)Pfizer Hospital Products Group, Inc.1992-01-31
STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS (K915002)Carrington Laboratories, Inc.1992-01-31
HEART PACK II (K914935)Westmark Hospital Supplies1992-01-31
AMSET LOCKING PLATE SYSTEM (K905023)Advanced Med/Surg, Inc.1992-01-31
PERRY(R) CUT-RESISTANT GLOVES (K914942)Smith & Nephew Perry1992-01-31
SIL-K (K914701)Degania Silicone , Ltd.1992-01-31
SUTURE REMOVAL KIT (K914932)Westmark Hospital Supplies1992-01-31
PROACT CLA-1500 SYSTEM (K915061)Clinical Systems, Inc.1992-01-31
CURITY VENTED DRESSING SYSTEM (K915635)Kendall Healthcare Products Co. Div.Of Tyco Health1992-01-31
HEART PACK III (K914933)Westmark Hospital Supplies1992-01-31
PULSE RATE MONITOR (K914595)Fitness Quest, Inc.1992-01-31
DGH-4000 A-SCAN/PACHYMETER (K913067)Dgh Technology, Inc.1992-01-31
SPECIAL PURPOSE COILS FOR GYREX V (K915598)Elscint, Inc.1992-01-31
DANTEC COUNTERPOINT MK2(TM) (K913957)Dantec Medical, Inc.1992-01-30
CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (K912027)Enzyme Technology, Inc.1992-01-30
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER (K912943)Health Products, Inc.1992-01-30
STREP A OIA (K915758)Biosearch Medical Products, Inc.1992-01-30
NAUDE URETHRAL STENT (K912851)Cook Urological, Inc.1992-01-30
THE STERN ERA SYSTEM (K913348)Sterngold/Implamed1992-01-30
OXYGEN TUBING, 81503 (K913422)Specialty Packaging Producs, Inc.1992-01-30
PROSPECT(TM) GIARDIA RAPID ASSAY (K915093)Alexon, Inc.1992-01-30
CHOLESTEROL REGEANT SET (K914160)Tech Intl. Co.1992-01-30
MILENIA DATA REDUCTION (K915806)Diagnostic Products Corp.1992-01-30
LIFECARE REMOTE ALARM II (K913423)Lifecare Services, Inc.1992-01-30
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION (K913859)Bivona Medical Technologies1992-01-30
E.R.C.P. CATHETER (K914495)Surgitek Medical Engineering Corp.1992-01-30
NEUROTRAC II (K914571)Moberg Medical, Inc.1992-01-30
AMYLASE (COLORIMETRIC) REAGENT SET (K915710)Tech Intl. Co.1992-01-30
CALIBRATOR (K915797)Alko Diagnostic Corp.1992-01-30
URETEROSCOPE (K915458)Psi Medical Products, Inc.1992-01-30
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR (K915769)Medtronic Vascular1992-01-30
CHOLEDOCHOSCOPE (K915681)Applied Laparoscopy1992-01-30
FIBRINOGEN FDP CONTROL (K915503)Cala Diagnostics1992-01-30
SPIROS (K915564)Life Support Products, Inc.1992-01-30
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST (K914885)Beckman Instruments, Inc.1992-01-30
AUDIOTONE MODEL A-96 (K920093)Miracle-Ear, Inc.1992-01-30
LOW BACK STRIP (OR) K-BACK (K912381)Katecho, Inc.1992-01-30
K-STIM (K913031)Katecho, Inc.1992-01-30
DWYER EYE SYSTEMS ASPIRATION UNIT (K913261)Spectracare, Inc.1992-01-30
PSF-50ET (K910850)Toshiba America Medical Systems, In.C1992-01-29
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM (K913986)Medical Dynamics, Inc.1992-01-28
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT (K915084)Beckman Instruments, Inc.1992-01-28
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM (K914166)Radiometer America, Inc.1992-01-28
DIMENSION AR CLINICAL CHEMISTRY SYSTEM (K915106)Dupont Medical Products1992-01-28
AUDIOTONE MODEL A97 (K920092)Miracle-Ear, Inc.1992-01-28
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL (K915516)Roche Diagnostic Systems, Inc.1992-01-28
MODEL TM101 TEMPERATURE MONITOR (K902386)Fisher & Paykel Electronics , Ltd.1992-01-28
DATASCOPE MODEL VISA CENTRAL MONITOR (K913576)Accucore, Inc.1992-01-28
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT (K915235)Incstar Corp.1992-01-28
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS) (K901507)Kirschner Medical Corp.1992-01-28
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT (K920046)Medix Biotech, Inc.1992-01-28
HORIZON 9000/HIS OPTION AMPLIFIER (K914381)Mennen Medical, Inc.1992-01-28
IL TEST(TM) BENZODIAZEPINE (K914815)Instrumentation Laboratory CO1992-01-27
PERMANENT PACING PAD, MODIFICATION (K915008)Oscor Medical Corp.1992-01-27
SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (K914022)Pharmacia Diagnostics, Inc.1992-01-27
PACEL(TM) FLOW DIRECTED PACING CATHETER (K914185)Daig Corp.1992-01-27
ATRAUMATIC TIP ANGIOGRAPHIC CATHETER (K915136)Exonix Research Corp.1992-01-27
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER (K913341)C.R. Bard, Inc.1992-01-27
VENUS HIP (K913708)Turnkey Intergration USA, Inc.1992-01-27
PERMANENT PACING LEADS, MODIFICATION (K915007)Oscor Medical Corp.1992-01-27
LAPAROSCOPIC SNARE POUCH (K915360)United States Endoscopy Group, Inc.1992-01-27
LM-90 ESU (K913799)Keisegang Medical, Inc.1992-01-27
CREATINE KINASE-MB (CK-MB) REAGENT SET (K915709)Tech Intl. Co.1992-01-27
GESCO PER-Q-CATH CATHETER INTRODUCER (K915167)Gesco Intl., Inc.1992-01-27
NOVA 11 NA/K/LI ANALYZER (K915178)Nova Biomedical Corp.1992-01-27
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT (K915570)Incstar Corp.1992-01-27
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION (K915701)Eastman Kodak Company1992-01-27
MP MINI PHOTOMETER (K914809)Artel, Inc.1992-01-27
SENSICARE SYNTHETIC MEDICAL GLOVES (K915478)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-01-27
DISPOSABLE SLIDE VALVE MANIFOLD (K913094)Professional Medical Services1992-01-27
SYNERMED AST/GOT REAGENT KIT (K915555)Synermed, Inc.1992-01-27
NOVA 5 NA/K/C1 ALALYZER (K915177)Nova Biomedical Corp.1992-01-27
GLUCOSE REAGENT SET (K914159)Tech Intl. Co.1992-01-27
HL-300 RECEIVER MODULE (K915879)Fukuda Denshi USA, Inc.1992-01-27
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION (K913773)Cobe Cardiovascular, Inc.1992-01-27
WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP (K914169)Dow Corning Wright1992-01-27
EVACUATION KIT #7-510-14 (K914861)Northgate Technologies, Inc.1992-01-27
CHIROFLEX II LENS MICROSERT(TM) (K914311)Chiron Ophthalmics1992-01-27
DIGITOXIN FPIA REAGENT SET (K915465)Sigma Diagnostics, Inc.1992-01-27
EMIT D.A.U. PHENCYCLIDINE ASSAY (K915728)Syva Co.1992-01-27
ACU-GUARD (K915000)Acuderm, Inc.1992-01-27
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (K914976)Vas-Cath, Inc.1992-01-27
DISPOSABLE VASCULAR ANGIOSCOPE (K914570)Nobles-Lai1992-01-27
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Every clearance here is in the API, with alerts when new ones post.