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

Filters: Cleared only ×
175,820 results
127849–127872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1990
KEMI LABS - ADHESIVE BANDAGE REMOVER
K895293 · KOX
Kemi Labs, Inc.
General & Plastic Surgery · 168d
Cleared Feb 09, 1990
SUCTION BIOPSY INSTRUMENT
K895420 · FCK
Mill-Rose Laboratory
Gastroenterology & Urology · 161d
Cleared Feb 09, 1990
FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER
K895506 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 150d
Cleared Feb 09, 1990
CONVEEN INTERMITTENT CATHETERS
K895548 · KOD
Coloplast A/S
Gastroenterology & Urology · 149d
Cleared Feb 09, 1990
JMS DIALYZER PRIMING SET
K895882 · KOC
Jms Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Feb 09, 1990
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING
K895885 · FCI
National-Standard Co.
Gastroenterology & Urology · 127d
Cleared Feb 09, 1990
BIOTEMP
K896018 · LGZ
Medadvances, Inc.
General Hospital · 116d
Cleared Feb 09, 1990
EOS IMPRESSION TRAYS
K896470 · EHY
Ivoclar North America, Inc.
Dental · 88d
Cleared Feb 09, 1990
H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR
K896473 · HPN
Emory University School of Medicine
Ophthalmic · 88d
Cleared Feb 09, 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · EJH
Leach and Dillon Co., Inc.
Dental · 87d
Cleared Feb 09, 1990
ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER
K896517 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Feb 09, 1990
PERMADYNE GARANT LOW VISCOSITY
K896539 · ELW
Espe GmbH (Us)
Dental · 86d
Cleared Feb 09, 1990
DENTAL CORE MATERIAL
K896564 · EBF
Dentsply Intl.
Dental · 84d
Cleared Feb 09, 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · JWY
Medical Specialties, Inc.
Microbiology · 81d
Cleared Feb 09, 1990
OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
K896821 · KOQ
North American Sterilization &...
Dental · 67d
Cleared Feb 09, 1990
LEUKOSILK(TM) SURGICAL TAPE
K896891 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 63d
Cleared Feb 09, 1990
MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER
K900043 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 09, 1990
MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
K900055 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 09, 1990
MONOPOLAR NEEDLE ELECTRODE
K900098 · HLW
Oculinum, Inc.
Ophthalmic · 32d
Cleared Feb 09, 1990
QUARTZ FIBER CATHETERS AND SURGICAL TIPS
K900144 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 29d
Cleared Feb 09, 1990
OCULINUM INJECTION AMPLIFIER
K900279 · HLW
Oculinum, Inc.
Ophthalmic · 32d
Cleared Feb 09, 1990
NAS&P GRASPING FORCEPS & ASSOC. DEVICES
K900401 · KOQ
North American Sterilization &...
Dental · 11d
Cleared Feb 09, 1990
ZEFAZONE SUSCEPTIBILITY POWDER
K900455 · LOP
The Upjohn Co.
Microbiology · 10d
Cleared Feb 09, 1990
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
K900487 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 17d