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
129721–129744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 15, 1989
TRIDENT DRAPE SUPPORT
K895011 · KKX
Trident Medical Products, Inc.
General Hospital · 38d
Cleared Sep 15, 1989
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · HWE
Zimmer, Inc.
Orthopedic · 35d
Cleared Sep 15, 1989
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
K895202 · LRO
Transidyne General Corp.
General & Plastic Surgery · 28d
Cleared Sep 15, 1989
IMS5000 ILLUMINATED LOUPES
K895248 · FSP
Luxtec Corp.
General & Plastic Surgery · 25d
Cleared Sep 15, 1989
SUNTANNING BED
K895325 · LEJ
Sunbronze
General & Plastic Surgery · 17d
Cleared Sep 15, 1989
ELECTROSURGICAL ELECTRODE
K895331 · JOS
New England Surgical Instrument Corp.
General & Plastic Surgery · 16d
Cleared Sep 15, 1989
ELECTROSURGICAL COAGULATION SUCTION TUBE
K895337 · HAM
New England Surgical Instrument Corp.
General & Plastic Surgery · 16d
Cleared Sep 14, 1989
PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
K884832 · CBK
Percussionaire Corp.
Anesthesiology · 300d
Cleared Sep 14, 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · JDI
Howmedica Corp.
Orthopedic · 92d
Cleared Sep 14, 1989
UNIVERSAL EYESHIELD
K894720 · HOY
Trident Medical Products, Inc.
Ophthalmic · 51d