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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117265–117288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1992
BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM
K921648 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 28d
Cleared May 04, 1992
AMBULATOR
K921752 · INM
The Anthros Medical Group
Physical Medicine · 21d
Cleared May 03, 1992
SANI-TIP
K920499 · ECB
Dw Industries, Inc.
Dental · 90d
Cleared May 01, 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640 · HWC
Concept, Inc.
Orthopedic · 322d
Cleared May 01, 1992
AUTOSTAT(TM) ANTI-DSNA
K913342 · LKJ
Cogent Diagnotics , Ltd.
Immunology · 280d
Cleared May 01, 1992
PFF-1
K914205 · BZG
Cybermedic, Inc.
Anesthesiology · 225d
Cleared May 01, 1992
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
K914256 · GKL
Intl. Remote Imaging Systems
Hematology · 221d
Cleared May 01, 1992
HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION
K914620 · DQA
Vitalog Monitoring,Inc.
Anesthesiology · 198d
Cleared May 01, 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · DQY
Cook, Inc.
Cardiovascular · 185d
Cleared May 01, 1992
CAMINO VENTRICULAR NEEDLE
K920088 · HCD
Camino Laboratories, Inc.
Neurology · 114d
Cleared May 01, 1992
THROMBIN CLOTTING TIME REAGENT
K920147 · GJA
Helena Laboratories
Hematology · 109d
Cleared May 01, 1992
SUNGLASSES
K920169 · HQY
Walgreen Co.
Ophthalmic · 109d
Cleared May 01, 1992
SUN/SPORTGLASSES
K920211 · HQY
Bacou USA, Inc. and Uvex Safety, Inc.
Ophthalmic · 106d
Cleared May 01, 1992
MITEK ANCHOR, MITEK ANCHOR II
K920213 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 106d
Cleared May 01, 1992
KODAK X-OMAT MODEL 180 LP PROCESSOR
K921269 · IXW
Eastman Kodak Company
Radiology · 45d
Cleared Apr 29, 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
K913117 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 289d
Cleared Apr 29, 1992
ENZYGNOST(R) TOXOPLASMOSIS/IGG
K913731 · LGD
Behring Diagnostics, Inc.
Microbiology · 253d
Cleared Apr 29, 1992
TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS
K914362 · KWQ
Acorn Group, Inc.
Orthopedic · 211d
Cleared Apr 29, 1992
RADIUS OSTEOTOMY PLATES
K914804 · HRS
Link America, Inc.
Orthopedic · 188d
Cleared Apr 29, 1992
REDDICK RETRACTOR
K915175 · GAD
Ideal Medical, Inc.
General & Plastic Surgery · 166d
Cleared Apr 29, 1992
MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES
K915502 · FYA
Medline
General Hospital · 142d
Cleared Apr 29, 1992
ELECTRODE, ION SPECIFIC
K915675 · JFP
Alko Diagnostic Corp.
Chemistry · 132d
Cleared Apr 29, 1992
AUQASOOTHE/AQUA MED
K915729 · ISA
Aquasoothe
Physical Medicine · 131d
Cleared Apr 29, 1992
ZIPPIE P500
K920179 · IOR
Sunrise Medical Quickie Designs, Inc.
Physical Medicine · 106d