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
84673–84696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1999
GOLD CORE 75
K993175 · EJT
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023 · LSK
Digene Corp.
Microbiology · 293d
Cleared Oct 25, 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 258d
Cleared Oct 25, 1999
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND...
K991140 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 203d
Cleared Oct 25, 1999
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385 · DCK
Dade Behring, Inc.
Immunology · 187d
Cleared Oct 25, 1999
MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
K991456 · MWY
Microwave Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 25, 1999
INTRAOP CATHETER
K991543 · MEB
I-Flow Corp.
General Hospital · 175d
Cleared Oct 25, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991696 · DZI
Stryker Instruments
Dental · 160d
Cleared Oct 25, 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853 · GWJ
Idem (Int'L Dist. of Electronics For...
Neurology · 146d
Cleared Oct 25, 1999
SCAREASE SHEETS & SCAREASE GEL
K991970 · MDA
Pillar Surgical
General & Plastic Surgery · 136d
Cleared Oct 25, 1999
VENTIL-A ORAL PROTECTOR
K992269 · JXL
Somatics, Inc.
Neurology · 111d
Cleared Oct 25, 1999
XRT 600 R/F, WRF 0600
K992603 · JAA
Wuestec Medical, Inc.
Radiology · 83d
Cleared Oct 25, 1999
AMIGO MODEL 680000 (AMIGO EXCITE F 350)
K992619 · ITI
Amigo Mobility Intl., Inc.
Physical Medicine · 82d
Cleared Oct 25, 1999
FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
K992627 · ITI
Teftec Corp.
Physical Medicine · 81d
Cleared Oct 25, 1999
FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
K992628 · ITI
Teftec Corp.
Physical Medicine · 81d
Cleared Oct 25, 1999
STENTOR, PAGEVIEW
K992698 · LMD
Stentor, Inc.
Radiology · 75d
Cleared Oct 25, 1999
SELECT-SUTTER MICRO BIPOLAR FORCEPS
K992760 · GEI
Select Medizintechnik Hermann Sutter...
General & Plastic Surgery · 69d
Cleared Oct 25, 1999
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796 · HCA
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Oct 25, 1999
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90...
K992837 · KTW
Synthes (Usa)
Orthopedic · 63d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 25, 1999
AMBU HAND POWER SUCTION PUMP
K992902 · BSY
Ambu, Inc.
Anesthesiology · 56d
Cleared Oct 25, 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · HRX
Hydrocision, Inc.
Orthopedic · 48d
Cleared Oct 25, 1999
PICCOLO SODIUM TEST SYSTEM
K993211 · JGS
Abaxis, Inc.
Chemistry · 31d
Cleared Oct 25, 1999
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · LKJ
Diamedix Corp.
Immunology · 24d