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
174145–174168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1977
SELFAST
K761355 · EMA
Septodont, Inc.
Dental · 5d
Cleared Dec 30, 1976
STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)
K760662 · FRG
C.R. Bard, Inc.
General Hospital · 104d
Cleared Dec 30, 1976
MULTI-TEST
K760699 · SCL
Lincoln Laboratories, Inc.
Immunology · 99d
Cleared Dec 30, 1976
WHOLE BLOOD PLATELET COUNTER -2510
K760765 · GKL
Clay Adams, Div. Becton Dickinson & Co.
Hematology · 87d
Cleared Dec 30, 1976
ADDITIVE CAP (2B8905)
K760880 · KPE
Travenol Laboratories, S.A.
General Hospital · 70d
Cleared Dec 30, 1976
CLEANING AND ISOLATION ROOM KIT
K760904 · FYC
American Hospital Supply Corp.
General Hospital · 65d
Cleared Dec 30, 1976
THERMOMETER JARS AND CAPS
K760909 · ELK
Plastics/Packaging
Dental · 65d
Cleared Dec 30, 1976
LAS-R HUMAN HAPTOGLOBIN TEST
K760917 · DFT
Hyland Therapeutic Div., Travenol...
Pathology · 63d
Cleared Dec 30, 1976
HOSPITALITY SERVER
K760934
Plastics/Packaging
General Hospital · 59d
Cleared Dec 30, 1976
DEVON COOL FACE
K760951 · KYR
Devon Industries, Inc.
General Hospital · 59d
Cleared Dec 30, 1976
CROWNTEX EXAM. CAPE & GOWN
K760954 · FME
Graham Manufacturing Co.
General Hospital · 58d
Cleared Dec 30, 1976
HEPARIN PUMP
K761050 · FIR
Dws, Inc.
Gastroenterology & Urology · 45d
Cleared Dec 30, 1976
BI-FLOW NEEDLE
K761051 · KOC
Dws, Inc.
Gastroenterology & Urology · 45d
Cleared Dec 30, 1976
COVENTRY STAPLE
K761064 · GDW
Depuy, Inc.
General & Plastic Surgery · 42d
Cleared Dec 30, 1976
P.S.M. BOUFFANT CAP
K761068 · FYF
The Owenby Co.
General & Plastic Surgery · 44d
Cleared Dec 30, 1976
P.S.M. BOTIQUE CAP
K761069 · FYF
The Owenby Co.
General & Plastic Surgery · 44d
Cleared Dec 30, 1976
P.S.M. SURGICAL HOOD
K761070 · FXY
The Owenby Co.
General Hospital · 44d
Cleared Dec 30, 1976
P.S.M. JUSTA KAP
K761071 · FYF
The Owenby Co.
General & Plastic Surgery · 44d
Cleared Dec 30, 1976
LASER STANDARD SERUM
K761235 · JZW
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Dec 30, 1976
ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.
K761236 · JZW
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Dec 30, 1976
PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE
K761241 · JTX
Gibco Laboratories Life Technologies,...
Microbiology · 17d
Cleared Dec 30, 1976
ANGIOTENSIN I IMMUTOPE KIT
K761267 · CIB
Squibb & Sons, Inc.
Immunology · 14d
Cleared Dec 30, 1976
IMMUNO-TEC II OT AGAROSE PLATE KIT
K761270 · JZP
Behring Diagnostics, Inc.
Immunology · 14d
Cleared Dec 30, 1976
DATA-TOPE T4 RIA PROCEDURE
K761282 · CDX
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 10d