Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81961–81984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Boston Scientific Corp
Cardiovascular · 239d
Cleared Sep 26, 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · DXQ
Cas Medical Systems, Inc.
Cardiovascular · 223d
Cleared Sep 26, 2000
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885 · LCP
Metrika, Inc.
Hematology · 190d
Cleared Sep 26, 2000
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K001022 · JZG
Biocheck, Inc.
Immunology · 180d
Cleared Sep 26, 2000
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
K001244 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 161d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Sep 26, 2000
JET 1 POWERED WHEELCHAIR
K001970 · ITI
Pride Mobility Products Corp.
Physical Medicine · 90d