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
80833–80856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228 · NCW
Bayer Corp.
Immunology · 455d
Cleared Sep 29, 2000
BIOSYS FETAL MONITOR, MODEL IFM-500
K994008 · HGM
Biosys Co. , Ltd.
Obstetrics & Gynecology · 310d
Cleared Sep 29, 2000
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
K994112 · NCW
Oncogene Science, Inc.
Immunology · 298d
Cleared Sep 28, 2000
PREFERENCE TREATMENT SYSTEM
K001833 · IYE
Northwest Medical Physics Equipment,...
Radiology · 104d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 73d
Cleared Sep 28, 2000
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · MOB
Cogent Diagnotics , Ltd.
Immunology · 66d
Cleared Sep 28, 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387 · EJI
Dentsply Intl.
Dental · 55d
Cleared Sep 28, 2000
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · EMA
3M Company
Dental · 49d
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...
K002711 · KGI
Hologic, Inc.
Radiology · 28d
Cleared Sep 28, 2000
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Sep 28, 2000
MODIFICATION TO PROFILE -II
K002776 · LCM
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Sep 28, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796 · LWJ
Stelkast Company
Orthopedic · 21d
Cleared Sep 28, 2000
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Sep 27, 2000
ORALUBE
K000847 · EFB
Orasystems
Dental · 196d
Cleared Sep 27, 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · GXY
Aspect Medical Systems, Inc.
Neurology · 90d
Cleared Sep 27, 2000
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984 · JDG
Stelkast Company
Orthopedic · 90d
Cleared Sep 27, 2000
SURGITRON IEC II
K001986 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 90d
Cleared Sep 27, 2000
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
K002039 · LLZ
Cti Pet Systems, Inc.
Radiology · 84d
Cleared Sep 27, 2000
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · LMC
Eastman Kodak Company
Radiology · 72d
Cleared Sep 27, 2000
WIRE, GUIDE, CATHETER, MODEL QSW1000
K002346 · DQX
Medtronic Ave, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d
Cleared Sep 27, 2000
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K002767 · DXC
Semler Technologies, Inc.
Cardiovascular · 21d
Cleared Sep 27, 2000
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · LIT
NuMED, Inc.
Cardiovascular · 474d
Cleared Sep 26, 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K000095 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 257d