Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WILTEK GRASPING FORCEPS (K894862)Wiltek Medical, Inc.1989-12-21
WILTEK PAPILLOTOME (K894861)Wiltek Medical, Inc.1989-12-21
WILTEK CYTOLOGY BRUSH (K894863)Wiltek Medical, Inc.1989-12-21
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER (K890999)Hologic, Inc.1989-12-21
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR (K896167)Pudenz-Schulte Medical Research Corp.1989-12-21
HEATED RESPIRATORY HUMIDIFIER (K892817)Fisher & Paykel Electronics , Ltd.1989-12-21
GYROVIEW HR HIGH RESOLUTION WORKSTATION (K896647)Philips Medical Systems North America, Inc.1989-12-21
WILTEK BILIARY STENT SET (K894871)Wiltek Medical, Inc.1989-12-21
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN (K896485)Empi1989-12-21
ORTHO-KEV APPLIANCE REINFORCING SYSTEM (K895714)American Orthodontics1989-12-21
WILTEK VARICES INJECTION NEEDLE (K894868)Wiltek Medical, Inc.1989-12-21
PLASTIC TOOTH REINFORCEMENT KIT (K895758)Nanzee Dental Products1989-12-20
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS (K896443)Possis Medical, Inc.1989-12-20
TOYOSUYA LATEX EXAMINATION GLOVES (K896489)Toyosuya Sdn Bhd1989-12-20
PATIENT EXAMINATION GLOVES (LATEX) (K892194)Pao Chen Industrial Co., Ltd.1989-12-20
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (K895447)Pacesetter Systems1989-12-20
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL) (K893800)Deringer-Ney, Inc.1989-12-20
TALLADIUM TILITE CERAMIC ALLOY (K894085)Talladium, Inc.1989-12-20
LATEX PATIENT EXAMINATION GLOVES (K894900)Fujian Ming Sheng Chemistry1989-12-20
REVISED PATIENT EXAMINATION GLOVES (K896411)Pt. Trihasta Loka Persada1989-12-20
NKA MODEL SEC-3102 CARDIAC STIMULATOR (K894492)Nihon Kohden America, Inc.1989-12-20
INFLATION PRO II (K895836)Baxter Healthcare Corp1989-12-20
BIOCHEM 3100 OXIMETER (K893877)Biochem International, Inc.1989-12-20
SELECT 40 (K895069)Leach and Dillon Co., Inc.1989-12-19
MICROMEDICS EAR, NOSE AND THROAT BURS (K895738)Micromedics, Inc.1989-12-19
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY (K894175)Serono-Baker Diagnostics, Inc.1989-12-19
SELECT 60 (K895067)Leach and Dillon Co., Inc.1989-12-19
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691)Bio-Rad1989-12-19
PANCREATIC A-AMYLASE EPS (K895880)Boehringer Mannheim Corp.1989-12-19
450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895063)Leach and Dillon Co., Inc.1989-12-19
HUI MINI-FLEX (K895659)Unimar, Inc.1989-12-19
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL (K896144)Cascade Medical, Inc.1989-12-19
SYS*STIM 207A (K893879)Mettler Electronics Corp.1989-12-19
COBAS READY (K896007)Roche Diagnostic Systems, Inc.1989-12-19
LOW FUSING WHITE GOLD (K895056)Leach and Dillon Co., Inc.1989-12-19
TDX(R) BARBITURATES II ASSAY (K896550)Abbott Laboratories1989-12-19
SELECT WHITE (K895070)Leach and Dillon Co., Inc.1989-12-19
.650 FINE GOLD SOLDER (K895054)Leach and Dillon Co., Inc.1989-12-19
SYS*STIM 206A (K893878)Mettler Electronics Corp.1989-12-19
750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895060)Leach and Dillon Co., Inc.1989-12-19
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' (K895807)Safeskin Corp.1989-12-18
TITAN AIR SPECTACLE FRAME (K896350)Acces Intl. Eyewear1989-12-18
JEDMED J-II CHAIR (K896275)Jedmed Instrument Co.1989-12-18
METAL URETERAL BASKET STONE DISLODGER (K896169)Annex Medical, Inc.1989-12-18
200 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895049)Leach and Dillon Co., Inc.1989-12-18
DIATECH IGM-MP TEST (K895276)Diatech Diagnostica , Ltd.1989-12-18
.730 FINE GOLD SOLDER (K895055)Leach and Dillon Co., Inc.1989-12-18
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (K896852)Ventrex Laboratories, Inc.1989-12-18
SELECT 50 (K895068)Leach and Dillon Co., Inc.1989-12-18
DIFCO OXIDASE DRYSLIDE (K896398)Difco Laboratories, Inc.1989-12-18
DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST (K893200)Gull Laboratories, Inc.1989-12-18
100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895050)Leach and Dillon Co., Inc.1989-12-18
MONOGRAM II (K895064)Leach and Dillon Co., Inc.1989-12-18
EBV-EA IFA KIT (K895652)Organon Teknika Treyburn1989-12-18
700 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895061)Leach and Dillon Co., Inc.1989-12-18
HIGH FUSING WHITE GOLD (K895057)Leach and Dillon Co., Inc.1989-12-18
MAINSTER WIDE FIELD LASER LENS (K896198)Ocular Instruments, Inc.1989-12-18
.585 FINE GOLD SOLDER (K895052)Leach and Dillon Co., Inc.1989-12-18
LITELINE VLC SOFT RELINE (K895742)Dentsply Intl.1989-12-18
DETECTADOT TM SYSTEM 2000 CMV IGM TEST (K893230)Gull Laboratories, Inc.1989-12-18
.615 FINE GOLD SOLDER (K895053)Leach and Dillon Co., Inc.1989-12-18
MONOGRAM III (K895065)Leach and Dillon Co., Inc.1989-12-18
LYNX-HIGH SPEED HANDPIECE (K895736)Mti Precision Products1989-12-18
TWO MIRROR GONIO LENS (K895846)Ocular Instruments, Inc.1989-12-18
MULTI-USE I/A HANDPIECE (K896305)Advanced Surgical Products, Inc.1989-12-18
CONDOM (RUBBER LATEX) KILROY (K894533)Rfsu1989-12-18
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (K895647)Advanced Technology Laboratories, Inc.1989-12-18
500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895062)Leach and Dillon Co., Inc.1989-12-18
MONOGRAM I (K895051)Leach and Dillon Co., Inc.1989-12-18
300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS (K895048)Leach and Dillon Co., Inc.1989-12-18
PERCUTANEOUS INTRAVENOUS CATHETERS (K895712)Pharmacia Deltec, Inc.1989-12-15
CATHETER CARE KITS (K894611)L H M Ent., Inc.1989-12-15
DIMENSION REVISION TOTAL HIP SYSTEM (K895636)Kirschner Medical Corp.1989-12-14
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) (K895408)Smith & Nephew United, Inc.1989-12-14
ACCUMED LATEX SURGICAL GLOVE (K893834)Accurate Medical Devices, Inc.1989-12-14
CONDOM (RUBBER LATEX) OKEIDO (K894534)Rfsu1989-12-14
KEY VASCULAR BOOTIES (K896472)Key Surgical, Inc.1989-12-14
RADIATION PROTECTION APRON (K896289)Infab Corp.1989-12-14
MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (K895837)Medical Laser, Inc.1989-12-14
HYSTEROFLATOR 2001 (K895907)Cabot Medical Corp.1989-12-14
CIVCO LATEX ULTRASOUND SHEATHS (K895614)CIVCO Medical Instruments Co., Inc.1989-12-14
STERILE DISPOSABLE INFRATIP (K895918)Heraeus Lasersonics, Inc.1989-12-14
RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (K894643)Lorad Medical Systems, Inc.1989-12-14
JAW BLOCKER (K896745)Plastic Engineered Products Co.1989-12-14
GYROSCAN T5 MOBILE (K895869)Philips Medical Systems, Inc.1989-12-14
KIM MODULAR FEMORAL HIP PROSTHESIS (K895399)Dow Corning Wright1989-12-14
SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY (K893136)Dyonics, Inc.1989-12-14
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT (K893994)Rich-Mar Corp.1989-12-14
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) (K896050)Fujifilm Medical System U.S.A., Inc.1989-12-14
PROFIL CONDOM (RUBBER LATEX) (K895894)Rfsu1989-12-14
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF (K894887)Shimadzu Medical Systems1989-12-14
QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM (K892711)Quantitative Cardiac Systems (Qcs), Inc.1989-12-14
BIRDS'N BEES CONDOMS (K895028)Rfsu1989-12-14
THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL (K895442)Altek Corp.1989-12-14
MT96000 PAPER CHART RECORDER (K894736)Astro-Med, Inc.1989-12-13
RED DOT CARDIAC SENSOR SYSTEM (K896155)3M Company1989-12-13
MODEL ELI-100/ST ELECTROCARDIOGRAPH (K895232)Mortara Instrument, Inc.1989-12-13
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES (K896490)Kendall Healthcare Products Co. Div.Of Tyco Health1989-12-13
GEL-TAC(R) (K895009)Padeco, Inc.1989-12-13
TEST ONE (K894662)Primed Products, Inc.1989-12-13
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.