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
127249–127272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1990
BITE BLOCK
K896691 · MNK
Endoscopix
Gastroenterology & Urology · 76d
Cleared Feb 12, 1990
(HEART) NEBULIZER
K896696 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 76d
Cleared Feb 12, 1990
BABE-EASE NEONATAL CLOTH ECG ELECTRODE
K896844 · GXY
Labeltape Meditect, Inc.
Neurology · 69d
Cleared Feb 12, 1990
MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
K900227 · LMD
Merge Technologies, Inc.
Radiology · 26d
Cleared Feb 09, 1990
ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA
K884962 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 448d
Cleared Feb 09, 1990
WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
K885309 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 408d
Cleared Feb 09, 1990
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
K891784 · FRC
Propper Mfg. Co., Inc.
General Hospital · 322d
Cleared Feb 09, 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · EGJ
Henley Intl.
Physical Medicine · 204d
Cleared Feb 09, 1990
AKS II
K895095 · LNJ
Amoco Technology Co.
Pathology · 179d
Cleared Feb 09, 1990
ADJUSTABLE SOFT PALATE LIFTER
K895189 · LRK
Ortho Publications, Inc.
Dental · 182d
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