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
95377–95400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1996
CEMENT-ON FEMORAL STEM
K963709 · JWH
Biomet, Inc.
Orthopedic · 79d
Cleared Dec 04, 1996
SOFT DENTURE REBASING RESIN
K963736 · EBI
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Dec 04, 1996
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
K963811 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 72d
Cleared Dec 04, 1996
PHONAK MICROLINK, PERSONAL FM RECEIVER
K964035 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Dec 04, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 50d
Cleared Dec 04, 1996
DE ORO 77
K964476 · EJT
Gateway Alloys, Inc.
Dental · 27d
Cleared Dec 03, 1996
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL...
K960970 · MCW
Possis Medical, Inc.
Cardiovascular · 267d
Cleared Dec 03, 1996
TFX MEDICAL GUIDEWIRE
K963320 · DQX
Tfx Medical Group
Cardiovascular · 102d
Cleared Dec 03, 1996
FERRITIN CALIBRATOR
K963493 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 91d
Cleared Dec 03, 1996
FIBREKOR
K964578 · EBF
Jeneric/Pentron, Inc.
Dental · 18d
Cleared Dec 02, 1996
FLEXIBLE MINI-FIBERSCOPES
K962172 · FBN
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 180d
Cleared Dec 02, 1996
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · DBF
Olympus America, Inc.
Immunology · 110d
Cleared Dec 02, 1996
MIDSTREAM ONESTEP PREGNANCY HOME TEST
K963341 · LCX
Syntron Bioresearch, Inc.
Chemistry · 98d
Cleared Dec 02, 1996
SPECTRA SCIENCE BIOPSY FORCEPS
K963517 · FCL
Spectrascience, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 02, 1996
THE WRAP IMMOBILIZATION SYSTEM
K963547 · FMQ
Safe Restraints, Inc.
General Hospital · 88d
Cleared Dec 02, 1996
COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A
K963705 · IYN
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 02, 1996
TOUCH N' HEAT
K963862 · EAT
Sybron Dental Specialties, Inc.
Dental · 69d
Cleared Dec 02, 1996
PATIENT RESTRAINTS
K963906 · FMQ
Safety Intl., Inc.
General Hospital · 63d
Cleared Dec 02, 1996
DAVOL PLUME FILTER (5541420)
K964211 · GEX
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 41d
Cleared Dec 02, 1996
OZARK 40
K964477 · EJT
Gateway Alloys, Inc.
Dental · 25d
Cleared Nov 29, 1996
SIMVIEW 3000 CT OPTION
K953233 · KPQ
Siemens Medical Solutions USA, Inc.
Radiology · 508d
Cleared Nov 29, 1996
CEP 8 SPECTRUMORANGE DNA PROBE KIT
K953591 · OYU
Vysis
Pathology · 486d
Cleared Nov 29, 1996
NEW COMFORT CONTACT LENS CARE ACCESSORY
K962112 · LYL
Lens Comfort, Inc.
Ophthalmic · 182d
Cleared Nov 29, 1996
ENZYMUN-TEST FT3
K962760 · CDP
Boehringer Mannheim Corp.
Chemistry · 136d