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
147217–147240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1985
SHARPLAN MODEL 1060 CO/2 SURGICAL LASER
K850633 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 169d
Cleared Aug 07, 1985
UROBEI STRESS INCONTINENCE MONITOR
K851483 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 07, 1985
DONWAY LIFTING FRAME
K851660 · FPP
Australian Biomedical Corporation , Ltd.
General Hospital · 106d
Cleared Aug 07, 1985
GENESYS GAMMA COUNTER
K851689 · JJJ
Laboratory Technologies, Inc.
Toxicology · 103d
Cleared Aug 07, 1985
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · KPQ
Victoreen, Inc.
Radiology · 103d
Cleared Aug 07, 1985
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K852014 · KOA
Effner and Spreine Co.
Gastroenterology & Urology · 90d
Cleared Aug 07, 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · KNX
The Kendal Co.
Gastroenterology & Urology · 86d
Cleared Aug 07, 1985
SIMPLASTIC SUPRA PUBIC CATHETER
K852200 · KOB
Franklin Medical USA, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 07, 1985
ESTEEM INCONTINENT SYSTEM
K852276 · EYQ
Bevan Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 07, 1985
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
K852353 · IXI
Thomson-Cgr Medical Corp.
Radiology · 65d
Cleared Aug 07, 1985
SUNBIRD (POWERED WHEELCHAIR)
K852379 · ITI
Venturego, Inc.
Physical Medicine · 63d
Cleared Aug 07, 1985
SPARROW MOTORIZED SCOOTER
K852380 · INI
Venturego, Inc.
Physical Medicine · 63d
Cleared Aug 07, 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · CFJ
Amresco, Inc.
Chemistry · 27d
Cleared Aug 07, 1985
BONE RONGEURS
K852993
The Huxley Instrument Corp.
General & Plastic Surgery · 23d
Cleared Aug 07, 1985
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · KLR
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Aug 07, 1985
STILLE ANGULAR RONGEUR, 8-3/4 SS 410
K853016
The Huxley Instrument Corp.
Dental · 21d
Cleared Aug 07, 1985
OPTIMATE DIGOXIN TEST
K853021 · DPB
Miles Laboratories, Inc.
Toxicology · 20d
Cleared Aug 07, 1985
TAN MODEL I
K853046 · FTC
Philip Munsterman Tan, Inc.
General & Plastic Surgery · 19d
Cleared Aug 07, 1985
RESPIR GARD-II FACE MASK CORRUGATED TUBING
K853056 · IYT
Marquest Medical Products, Inc.
Radiology · 19d
Cleared Aug 07, 1985
MEDUS GMBH
K853153 · GEN
Corkes Medical Co.
General & Plastic Surgery · 9d
Cleared Aug 06, 1985
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · BWF
American Pharmaseal Div. Ahsc
Anesthesiology · 127d
Cleared Aug 06, 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
K851618 · CGA
Home Diagnostics, Inc.
Chemistry · 110d
Cleared Aug 06, 1985
MEDI-COMP NEONATAL OXYGEN HOOD
K851666 · BYL
Medicomp, Inc.
Anesthesiology · 105d
Cleared Aug 06, 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · DRS
Honeywell, Inc.
Cardiovascular · 97d