FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125089–125112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1990
FLEXIBLE SNARE
K902265 · FDI
Annex Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 27, 1990
HEMA-SCREEN
K902360 · KHE
Immunostics Co., Inc.
Hematology · 59d
Cleared Jul 27, 1990
GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
K902481 · FJI
Gambro, Inc.
Gastroenterology & Urology · 52d
Cleared Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
K902500 · HKO
Nidek, Inc.
Ophthalmic · 52d
Cleared Jul 27, 1990
EMIT(R) II OPIATE ASSAY
K902577 · DJG
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · DIO
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581 · DKB
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
CUT RESISTANT GLOVE LINER
K902633 · LYU
Biomet, Inc.
General Hospital · 43d
Cleared Jul 27, 1990
BPA, BODY POSITION ALARM
K902669 · LZW
Bagrad
Physical Medicine · 39d
Cleared Jul 27, 1990
SECUTAINER
K902709 · JKA
Preserve
Chemistry · 37d
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