FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92449–92472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1997
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · DJR
Beckman Instruments, Inc.
Toxicology · 35d
Cleared Sep 19, 1997
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
K965154 · LRT
Albert Browne , Ltd.
General Hospital · 270d
Cleared Sep 19, 1997
DIGI-INJECTOR
K971067 · MRH
Medical Instrument Development...
Ophthalmic · 179d
Cleared Sep 19, 1997
DINAMAP MPS PORTABLE MONITOR
K971569 · MSX
Johnson & Johnson Medical, Inc.
Cardiovascular · 143d
Cleared Sep 19, 1997
DIGENE CERVICAL BRUSH
K971586 · HHT
Digene Corp.
Obstetrics & Gynecology · 141d
Cleared Sep 19, 1997
PIONEER ELEC-TROCAR DEVICE
K971728 · GEI
Pioneer Surgical Technology
General & Plastic Surgery · 133d
Cleared Sep 19, 1997
GR100F URINE FLOWMETER
K971913 · EXY
Albyn Medical , Ltd.
Gastroenterology & Urology · 120d
Cleared Sep 19, 1997
KENTRON'S ISOLATION GOWN
K971917 · FYC
Kentron Health Care, Inc.
General Hospital · 119d
Cleared Sep 19, 1997
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
K971984 · MCW
Microvena Corp.
Cardiovascular · 113d
Cleared Sep 19, 1997
ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES
K972008 · GEI
European Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Sep 19, 1997
PULSEMASTER 1000 ST DENTAL LASER SYSTEM
K972325 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 88d
Cleared Sep 19, 1997
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
K972347 · GEX
Lumenis, Inc.
General & Plastic Surgery · 87d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Sep 19, 1997
IMPERVIOUS ISOLATION GOWN
K972410 · FYC
Kentron Health Care, Inc.
General Hospital · 85d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Sep 19, 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · MGP
Courtaulds Fibers, Inc.
General & Plastic Surgery · 80d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · MNH
Depuy, Inc.
Orthopedic · 71d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Sep 19, 1997
IN-SLING
K972651 · OTN
Influence, Inc.
Gastroenterology & Urology · 67d
Cleared Sep 19, 1997
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K972679 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 65d
Cleared Sep 19, 1997
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · HSB
Zimmer, Inc.
Orthopedic · 64d
Cleared Sep 19, 1997
OT-1
K972781 · FED
Prism Therapeutics, LLC
Gastroenterology & Urology · 56d
Cleared Sep 19, 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · LYY
Ansell Perry
General Hospital · 56d
Cleared Sep 19, 1997
AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
K972901 · GEI
American Biosurgical, Inc.
General & Plastic Surgery · 44d