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
167977–168000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1979
DISPOSABLE PERITONEAL DIALYSIS EXTENSION
K791722 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 16, 1979
RING-ORIFICE, TURBULENT FLOW PNEUMOT
K791730 · JAX
Research Development Corp.
Anesthesiology · 80d
Cleared Nov 16, 1979
ROTAZYME
K791746 · LFX
Abbott Laboratories
Microbiology · 67d
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · JSS
3M Company
Microbiology · 63d
Cleared Nov 16, 1979
HYDRON BURN DRESSING FIELD KIT
K791865 · KMF
National Patent Development Corp.
General & Plastic Surgery · 56d
Cleared Nov 16, 1979
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · JOW
3M Company
Cardiovascular · 52d
Cleared Nov 16, 1979
BARNES-HIND WETTING & SOAKING SOLUTION
K791901 · HQG
Barnes-Hind, Inc.
Ophthalmic · 52d
Cleared Nov 16, 1979
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948 · GQH
Intl. Diagnostic Technology
Microbiology · 46d
Cleared Nov 16, 1979
MEVATRON 74X MEDICAL LINEAR ACCELERATOR
K791967 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 45d
Cleared Nov 16, 1979
HYGENIC RUBBER DAM LUBRICANT
K791970 · KMJ
The Hygenic Corp.
General Hospital · 45d
Cleared Nov 16, 1979
TC02M PRECISION GAS CALIBRATOR
K792011 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 42d
Cleared Nov 16, 1979
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · FMF
Medline Industries, Inc.
General Hospital · 37d
Cleared Nov 16, 1979
SAFE RETURN COT. #9675 & CONNECTOR ADAPT
K792044 · GEI
Concept, Inc.
General & Plastic Surgery · 35d
Cleared Nov 16, 1979
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT
K792056 · JSC
Fisher Scientific Co., LLC
Microbiology · 32d
Cleared Nov 16, 1979
MEMCO 300 FILM CHANGER
K792068 · KPX
Memco, Inc.
Radiology · 32d
Cleared Nov 16, 1979
HAAG-STREIT SLIT LAMP 900
K792083 · HRM
Lumenis, Inc.
General & Plastic Surgery · 31d
Cleared Nov 16, 1979
2 FR KELMAN CHAMBER MAINTAINER
K792096 · FMI
Heyer Schulte Corp.
General Hospital · 29d
Cleared Nov 16, 1979
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K792102 · KGX
National Patent Development Corp.
General & Plastic Surgery · 28d
Cleared Nov 16, 1979
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K792103 · KGX
National Patent Development Corp.
General & Plastic Surgery · 28d
Cleared Nov 16, 1979
CONPHAR 100% SILICONE FOLEY CATH-STER.
K792107 · KOD
Conphar, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 16, 1979
CONPHAR LATEX FOLEY CATH-STERILE
K792109 · KOD
Conphar, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 16, 1979
CONPHAR SILICONE COATED FOLEY CATH
K792111 · KOD
Conphar, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 16, 1979
3388 REPORTING INTEGRATOR
K792158 · JQP
Hewlett-Packard Co.
Toxicology · 18d
Cleared Nov 16, 1979
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 18d