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
116761–116784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1992
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
K915622 · JAQ
Nucletron-Oldelft Corp.
Radiology · 284d
Cleared Sep 25, 1992
HEMOLAB SILIMAT REAGENT
K920001 · GFI
Biomerieux Vitek, Inc.
Hematology · 267d
Cleared Sep 25, 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · LJC
Syva Co.
Microbiology · 233d
Cleared Sep 25, 1992
BLUNT TIP IRRIGATION NEEDLES
K921354 · EKJ
Innovators, Inc.
Dental · 189d
Cleared Sep 25, 1992
WINGMASTER
K921355 · EHB
Innovators, Inc.
Radiology · 189d
Cleared Sep 25, 1992
OCCLUSION BALLON CATHETER MODIFICAION
K921399 · DXC
Interventional Therapeutics Corp.
Cardiovascular · 185d
Cleared Sep 25, 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · LJC
Syva Co.
Microbiology · 182d
Cleared Sep 25, 1992
AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
K922457 · MJK
Microprobe Corp.
Microbiology · 122d
Cleared Sep 25, 1992
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
K923133 · MJM
Microprobe Corp.
Microbiology · 88d
Cleared Sep 25, 1992
KODAK AMERLITE TOTAL THYROID CONTROL SERA
K923740 · JJY
Eastman Kodak Company
Chemistry · 60d
Cleared Sep 25, 1992
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886 · MID
Shield Diagnostics, Ltd.
Immunology · 52d
Cleared Sep 25, 1992
ENCORE RHEUMATOID FACTOR EIA
K924056 · DHR
Clark Laboratories, Inc.
Immunology · 44d
Cleared Sep 23, 1992
ALPINE V
K914916 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 324d
Cleared Sep 23, 1992
UMBILICAL CLAMP
K915569 · HFW
Gam Industries, Inc.
Obstetrics & Gynecology · 286d
Cleared Sep 23, 1992
URETERAL STENT
K920695 · FAD
Applied Urology, Inc.
Gastroenterology & Urology · 222d
Cleared Sep 23, 1992
KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.
K921054 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 202d
Cleared Sep 23, 1992
FORCE 1C
K921222 · HGI
Valleylab, Inc.
Obstetrics & Gynecology · 194d
Cleared Sep 23, 1992
NEW STACHROM ANTIPLASMIN
K921449 · GGP
American Bioproducts Co.
Hematology · 181d
Cleared Sep 23, 1992
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · CIN
Helena Laboratories
Chemistry · 174d
Cleared Sep 23, 1992
BIO-GUARD LATEX SURGICAL GLOVES
K921664 · KGO
Network Medical Systems, Inc.
General Hospital · 169d
Cleared Sep 23, 1992
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
K921674 · FPA
Strato Medical Corp.
General Hospital · 168d
Cleared Sep 23, 1992
GLUCOSE 3
K922035 · CGA
Caro Med, Inc.
Chemistry · 145d
Cleared Sep 23, 1992
BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS
K922523 · GEI
Ximed Medical Systems
General & Plastic Surgery · 118d
Cleared Sep 23, 1992
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 111d