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
132961–132984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1989
ACETABULAR CUP PUSHER/IMPACTOR
K885305 · HXO
Cobot Medical Corp.
Orthopedic · 43d
Cleared Feb 08, 1989
DACOMED EXTERNAL MALE CONTINENCE DEVICE
K885323 · FHA
Dacomed Corp.
Gastroenterology & Urology · 42d
Cleared Feb 08, 1989
ZIPPIE & QUICKIE 2HP WHEELCHAIR
K890050 · IOR
Motion Designs, Inc.
Physical Medicine · 33d
Cleared Feb 08, 1989
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K890054 · JDI
Protek, Inc.
Orthopedic · 33d
Cleared Feb 08, 1989
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111 · FJI
Gambro, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 08, 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 16d
Cleared Feb 07, 1989
CRACK-IT CHAP SCREEN
K874389 · DMN
Sakers, Inc.
Toxicology · 469d
Cleared Feb 07, 1989
STANBIO MAGNESIUM TEST SET, CAT. NO 0130
K883170 · JGJ
Stanbio Laboratory
Chemistry · 195d
Cleared Feb 07, 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 141d
Cleared Feb 07, 1989
CEDIA THEOPHYLLINE ASSAY
K884358 · KLS
Microgenics Corp.
Toxicology · 113d
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · GRP
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · GTZ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004 · GTJ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
CAPILLARY TUBE, BLOOD COLLECTION
K885138 · GIO
Coeur Laboratories, Inc.
Hematology · 54d
Cleared Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 47d
Cleared Feb 07, 1989
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
K885269 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 47d
Cleared Feb 07, 1989
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE
K885288 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0
K885289 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · LGD
Labsystems, Inc.
Microbiology · 26d
Cleared Feb 07, 1989
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
K890183 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
K890184 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER
K890279 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 26d