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
149353–149376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1985
CHLAMYDIA GROUP CF ANTIGEN
K844868 · GPW
Hillcrest Biologicals
Microbiology · 81d
Cleared Mar 05, 1985
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K844906 · LZO
Depuy, Inc.
Orthopedic · 78d
Cleared Mar 05, 1985
CFE ACETABULAR CUP
K844941 · JDI
Biomet, Inc.
Orthopedic · 75d
Cleared Mar 05, 1985
LEUCINE AMINOPEPTIDASE REAGENT
K844965 · JGG
Alladin Diagnostic, Inc.
Chemistry · 71d
Cleared Mar 05, 1985
ECHO TYPE 9 CF ANTIGEN
K844967 · GNL
Hillcrest Biologicals
Microbiology · 71d
Cleared Mar 05, 1985
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE
K845008 · KZJ
Marion Laboratories, Inc.
Microbiology · 69d
Cleared Mar 05, 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · KYG
Jedmed Instrument Co.
Ophthalmic · 67d
Cleared Mar 05, 1985
COXSACKIE B SERIES CF ANTIGENS
K850003 · GNG
Hillcrest Biologicals
Microbiology · 62d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017 · JJY
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Mar 05, 1985
SANYO ELECTRONIC MUSCLE STIMULATORS
K850047 · IPF
General Physiotherapy, Inc.
Physical Medicine · 56d
Cleared Mar 05, 1985
ANAEROBE KIT
K850052 · JSP
Austin Biological Laboratories
Microbiology · 56d
Cleared Mar 05, 1985
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K850079 · LCX
Bioclinical Systems, Inc.
Chemistry · 54d
Cleared Mar 05, 1985
CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS
K850131 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 50d
Cleared Mar 05, 1985
SPORDEX CULTURE MEDIA
K850143 · JSC
American Sterilizer Co.
Microbiology · 50d
Cleared Mar 05, 1985
ISOCONTROL SERUM CK-MB
K850213 · JJT
Sclavo, Inc.
Chemistry · 49d
Cleared Mar 05, 1985
ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM
K850221 · KIT
Hazleton Research Products, Inc.
Microbiology · 42d
Cleared Mar 05, 1985
HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED-
K850222 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
WAYMOUTH'S MEDIUM MB 752/1
K850224 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
RPMI-1603 MEDIUM
K850229 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
RPMI-1634 MEDIUM
K850230 · KIT
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
ALPHA MEM MEDIUM W/O NUCLEOSIDES
K850231
Hazleton Research Products, Inc.
Pathology · 42d
Cleared Mar 05, 1985
BCS GLUCOSE COLORIMETRIC TEST
K850257 · CGA
Bioclinical Systems, Inc.
Chemistry · 42d
Cleared Mar 05, 1985
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
K850298 · FEO
Cabot Medical Corp.
Gastroenterology & Urology · 40d
Cleared Mar 05, 1985
DISPOS. CONDUCTIVE ADHESIVE TENS PAD
K850311 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 39d