FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125689–125712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1990
AMERSHAM TSH CONTROL SERA
K902760 · JJX
Amersham Corp.
Chemistry · 32d
Cleared Jul 27, 1990
TOTAL IRON FOR MANUAL/AUTOMATED
K902877 · JIY
Catachem, Inc.
Chemistry · 25d
Cleared Jul 27, 1990
MICROZYME T4 ENZYME IMMUNOASSAY KIT
K902922 · CDX
Immunotech Corp.
Chemistry · 24d
Cleared Jul 27, 1990
SYNERMED TRIGLYCERIDES REAGENT KIT
K903016 · CDT
Synermed, Inc.
Chemistry · 17d
Cleared Jul 27, 1990
HERITAGE III (HTC) ITC TYPE HEARING AID
K903023 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 27, 1990
ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002
K903213 · HEX
Percutaneous Technologies
Obstetrics & Gynecology · 4d
Cleared Jul 26, 1990
METRICARE DRUG RESERVOIRS
K895924 · KPE
Metrix Co.
General Hospital · 288d
Cleared Jul 26, 1990
PHARMACIA MUMPS IGG ELISA
K897006 · LJY
Pharmacia Eni Diagnostics, Inc.
Microbiology · 220d
Cleared Jul 26, 1990
DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
K900604 · KHW
Biovir Laboratories, Inc.
Microbiology · 168d
Cleared Jul 26, 1990
BAXTER D & C TRAY
K901442 · HCY
Baxter Healthcare Corp
Obstetrics & Gynecology · 121d
Cleared Jul 26, 1990
INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
K901928 · EGG
Interpore Intl.
Dental · 90d
Cleared Jul 26, 1990
AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC
K901954 · HFW
Hollister, Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 26, 1990
EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER
K902042 · DSB
Em-Scan, Inc.
Cardiovascular · 83d
Cleared Jul 26, 1990
RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
K902092 · FRN
Critikon Company, LLC
General Hospital · 78d
Cleared Jul 26, 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Jul 26, 1990
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K902350 · EBH
Kulzer, Inc.
Dental · 62d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL I
K902361 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL II
K902362 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL III
K902363 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COHERENT XA30/SP AND XA50 SURGICAL LASERS
K902470 · GEX
Lumenis, Inc.
General & Plastic Surgery · 52d
Cleared Jul 26, 1990
VAAKA BABY SCALE
K902545 · FRW
Ferguson Medical
General Hospital · 48d
Cleared Jul 26, 1990
VISI-SWAB OPHTALMIC SPONGE
K902750 · HOZ
Visitec Co.
Ophthalmic · 34d
Cleared Jul 26, 1990
ZENITH HYLO AND VERTI-LIFT CHIROPRACTIC TABLES
K902971 · INQ
Williams Manufacturing Co.
Physical Medicine · 20d
Cleared Jul 25, 1990
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
K900170 · JAK
Elscint, Inc.
Radiology · 194d