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
152761–152784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1984
OSLO ARMCHAIR
K841725 · INM
Mondial, Inc.
Physical Medicine · 14d
Cleared May 09, 1984
PHAMAS ALLERGY MGMT. SYSTEM
K841915
Pharmacia, Inc.
Microbiology
Cleared May 07, 1984
FOGCUTTER DENTAL MOUTH MIRROR
K833310 · EAX
Hti, Inc.
Dental · 224d
Cleared May 07, 1984
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · GKA
Beckman Instruments, Inc.
Hematology · 129d
Cleared May 07, 1984
BIODEX ACT-O-KIT TSH-RIA-
K840088 · JLW
Biodan Medical Systems, Ltd.
Chemistry · 118d
Cleared May 07, 1984
CORNING IMMO PHASE FREE T3
K840222 · CDP
Corning Medical & Scientific
Chemistry · 109d
Cleared May 07, 1984
AMBULARM
K840295 · KMI
Rigi Systems, Inc.
General Hospital · 104d
Cleared May 07, 1984
MICROTRAK HSV 1 & 2 CULTURE
K840494 · GQL
Syva Co.
Microbiology · 91d
Cleared May 07, 1984
CK-B RIA KIT
K840549 · JHX
Diagnostic Systems Laboratories, Inc.
Chemistry · 89d
Cleared May 07, 1984
SWEEN-A-PEEL PERISTOMAL WAFERS
K840723 · EXB
Sween Corp.
Gastroenterology & Urology · 76d
Cleared May 07, 1984
CENTRIFUGES
K840768 · JQC
Heraeus-Christ GmbH
Hematology · 74d
Cleared May 07, 1984
ION SELECTIVE ELECTRODE
K841076 · JJE
Cooper Biomedical, Inc.
Chemistry · 56d
Cleared May 07, 1984
VENTREZYME BETA-HCG IMMUNOASSAY HCG
K841081 · JHI
Ventrex Laboratories, Inc.
Chemistry · 55d
Cleared May 07, 1984
HUMAN GROWTH HORMONE RIA KIT
K841094 · CFL
Diagnostic Products Corp.
Chemistry · 55d
Cleared May 07, 1984
DETERMINATION OF MAGNESIUM IN SERUM OR
K841259 · JGJ
Sigma Chemical Co.
Chemistry · 42d
Cleared May 07, 1984
EMPI MODEL 712, LOGIX, NMS
K841382 · IPF
Empi
Physical Medicine · 35d
Cleared May 07, 1984
SHOWER TROLLEY
K841395 · FSA
Setma, Inc.
General Hospital · 34d
Cleared May 07, 1984
TRANSFER TROLLEY
K841396 · FDA
Setma, Inc.
Gastroenterology & Urology · 34d
Cleared May 07, 1984
VARIABLE HEIGHT TRANSFER CHAIR
K841398 · FSA
Setma, Inc.
General Hospital · 34d
Cleared May 07, 1984
AB VACUUM EXTRACTOR SILC-CUP
K841492 · HDB
Medela, Inc.
Obstetrics & Gynecology · 27d
Cleared May 07, 1984
MUELLER-HINTON BROTH
K841560 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 20d
Cleared May 07, 1984
HYPODERMIC NEEDLES
K841577 · FMI
Ava Medical Products of Canada, Inc.
General Hospital · 20d
Cleared May 07, 1984
DISPOSABLE SYRINGE
K841578 · FMF
Ava Medical Products of Canada, Inc.
General Hospital · 20d
Cleared May 07, 1984
RHESUS SV5/SV40
K841665 · KIR
Viromed Laboratories, Inc.
Pathology · 14d