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
129121–129144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1989
SLT CONTACT LASER SYSTEMS
K895093 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Sep 18, 1989
SPINOCAN(R) CONTINUOUS SPINAL TRAY
K895192 · CAZ
Burron Medical, Inc.
Anesthesiology · 38d
Cleared Sep 18, 1989
CALIFORNIA COMFORT FOUR WHEEL
K895384 · IQC
Jubilee Scooters, Inc.
Physical Medicine · 19d
Cleared Sep 15, 1989
LATEX EXAMINATION GLOVES
K890803 · LYY
A-Tek Medical Supply
General Hospital · 211d
Cleared Sep 15, 1989
SUNNY TEX (PATIENT EXAMINATION GLOVES)
K892021 · LYY
P.T. Indotama Megah Indah Rubber
General Hospital · 169d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892095 · LYY
Madafair , Ltd.
General Hospital · 165d
Cleared Sep 15, 1989
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · JXA
Gen-Probe, Inc.
Microbiology · 165d
Cleared Sep 15, 1989
DENTAL PIK
K892861 · EKS
U.S. Dentek Corp.
Dental · 150d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K892992 · LYY
Cypress Ent.
General Hospital · 156d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K893020 · LYY
Dover Products, Inc.
General Hospital · 155d
Cleared Sep 15, 1989
LATEX EXAMINATION GLOVES
K893275 · LYY
Pt Ika Muda Corpora
General Hospital · 151d
Cleared Sep 15, 1989
VINYL EXAMINATION GLOVES
K893338 · LYZ
Taiwan an Lih Ent. Co. , Ltd.
General Hospital · 148d
Cleared Sep 15, 1989
PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
K893762 · JWH
Orthomet, Inc.
Orthopedic · 119d
Cleared Sep 15, 1989
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K893919 · CAI
Baxter Healthcare Corp
Anesthesiology · 108d
Cleared Sep 15, 1989
LATEX EXAMINATION GLOVES
K893929 · LYY
Ever Growing Ent. Co., Ltd.
General Hospital · 107d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K894007 · LYY
Pre Lotus Industrial Sdn. Bhd.
General Hospital · 105d
Cleared Sep 15, 1989
LUMINA ORTHODONTIC BRACKET
K894358 · EJF
Ormco Corp.
Dental · 63d
Cleared Sep 15, 1989
PATIENT EXAMINATION GLOVES
K894480 · LYY
Pt. Intan Hevea Industry
General Hospital · 59d
Cleared Sep 15, 1989
COTOLIN DRAIN SPONGE AND DRESSING SPONGE
K894505 · EFQ
James River Corp.
General & Plastic Surgery · 58d
Cleared Sep 15, 1989
BICARBONATE TEST ITEM NUMBER: 65412
K894509 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Sep 15, 1989
FPR THEOPHYLLINE KIT
K894529 · LGS
Colony Laboratories, Inc.
Toxicology · 57d
Cleared Sep 15, 1989
BEAMER ONE
K894663 · HAM
Beacon Laboratories, Inc.
General & Plastic Surgery · 53d
Cleared Sep 15, 1989
B100 DISPOSABLE HANDPIECE
K894762 · HAM
Beacon Laboratories, Inc.
General & Plastic Surgery · 50d
Cleared Sep 15, 1989
OPTIFLEX
K894781 · EJF
Ormco Corp.
Dental · 49d