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
94249–94272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1997
IMT LOUPE-COLPOSCOPE
K963593 · HEX
Inventive Medical Technology
Obstetrics & Gynecology · 225d
Cleared Apr 22, 1997
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
K963731 · DWJ
Enthermics Medical Systems, Inc.
Cardiovascular · 217d
Cleared Apr 22, 1997
HYDRAGEL 15 HB A1C KIT
K963844 · LCP
Morax
Hematology · 209d
Cleared Apr 22, 1997
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K963850 · CAC
Deknatel, Inc.
Anesthesiology · 209d
Cleared Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · IYN
Hewlett-Packard Co.
Radiology · 175d
Cleared Apr 22, 1997
RESECTOSCOPE CUTTING LOOP ELECTRODE
K964365 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Apr 22, 1997
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
K964440 · KGO
Maxxim Medical
General Hospital · 167d
Cleared Apr 22, 1997
PROSELECT 3 PERIDONTAL THERAPY SYSTEM
K964596 · ELC
Professional Dental Mfg., Inc.
Dental · 155d
Cleared Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
K964742 · LFL
Aziz Y. Anis, M.D.
General & Plastic Surgery · 147d
Cleared Apr 22, 1997
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K965095 · LZA
Ansell Edmont Industrial, Inc.
General Hospital · 124d
Cleared Apr 22, 1997
VINYL EXAM GLOVE POWERED
K970144 · LYZ
Hiyi Export Co.
General Hospital · 97d
Cleared Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · KPI
Empi
Gastroenterology & Urology · 85d
Cleared Apr 22, 1997
EQUI-PISE 1000 MRS
K970350 · FNM
Advanced Air Support Consultancy, Inc.
General Hospital · 82d
Cleared Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
K970394 · MEH
Osteonics Corp.
Orthopedic · 78d
Cleared Apr 22, 1997
SAFE-CONNECT I.V. EXTENSION SET
K970524 · FPA
Faulding Medical Device Co.
General Hospital · 70d
Cleared Apr 22, 1997
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
K970764 · OCX
Comeg Endoscopy
Gastroenterology & Urology · 50d
Cleared Apr 22, 1997
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
K970966 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 21, 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
K941707 · DEH
Ventana Medical Systems, Inc.
Immunology · 1111d
Cleared Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · GGP
The Binding Site, Ltd.
Hematology · 742d
Cleared Apr 21, 1997
VAIL 3000 BED ENCLOSURE
K963589 · FNL
Vail Products, Inc.
General Hospital · 224d
Cleared Apr 21, 1997
JANUS I
K963863 · IYO
3D Ultrasound, Inc.
Radiology · 207d
Cleared Apr 21, 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 179d
Cleared Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · GWG
Aesculap, Inc.
Neurology · 175d
Cleared Apr 21, 1997
IN THE EAR HEARING AID
K964898 · ESD
Keytone Hearing Laboratory
Ear, Nose, Throat · 136d