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
81265–81288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2000
VIVANT BREAST LESION LOCALIZATION DEVICE
K003439 · KNW
Vivant Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Dec 15, 2000
PROTRACT PRESS FIT HIP STEM
K003447 · LPH
Stelkast Company
Orthopedic · 39d
Cleared Dec 15, 2000
X-POSURE SYSTEM VERSION 2 MAMMO
K003656 · KGI
Pronosco A/S
Radiology · 18d
Cleared Dec 15, 2000
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
K003711 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 14d
Cleared Dec 15, 2000
BIRD TBIRD LEGACY VENTILATOR
K003770 · CBK
Bird Products Corp.
Anesthesiology · 9d
Cleared Dec 15, 2000
ACE AIM TTC FUSION NAIL
K003797 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 7d
Cleared Dec 14, 2000
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS:...
K000834 · EFB
Castellini S.P.A.
Dental · 275d
Cleared Dec 14, 2000
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K002506 · CAH
Sims Portex, Inc.
General Hospital · 121d
Cleared Dec 14, 2000
PROCLUDE
K002989 · EJR
Ortek Therapeutics, Inc.
Dental · 80d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · DHA
Roche Diagnostics Corp.
Chemistry · 64d
Cleared Dec 14, 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228 · MKJ
Katecho, Inc.
Cardiovascular · 59d
Cleared Dec 14, 2000
CREATININE
K003247 · CGX
Jas Diagnostics, Inc.
Chemistry · 58d
Cleared Dec 14, 2000
METALYZER, MODEL 2
K993641 · BTY
Cortex Biophysik GmbH
Anesthesiology · 413d
Cleared Dec 14, 2000
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K994337 · MQV
Orthovita Co.
Orthopedic · 357d
Cleared Dec 13, 2000
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
K001233 · FPA
R-Group Intl.
General Hospital · 240d
Cleared Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
K001254 · JDQ
Orthomatrix, Inc.
Orthopedic · 238d
Cleared Dec 13, 2000
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · GWJ
Ics Medical Corp.
Neurology · 79d
Cleared Dec 13, 2000
PRO-FEMUR R
K003016 · LWJ
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Dec 13, 2000
COPELAND RESURFACING HEADS
K003044 · HSD
Biomet, Inc.
Orthopedic · 75d
Cleared Dec 13, 2000
OVARIAL BIOPSY SET 324102-324108
K003056 · MQE
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 73d
Cleared Dec 13, 2000
CALEO
K003067 · FMZ
Drager Medizintechnik GmbH
General Hospital · 72d
Cleared Dec 13, 2000
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K003071 · LPL
Ciba Vision Corporation
Ophthalmic · 72d
Cleared Dec 13, 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144 · MOS
Medical Advances, Inc.
Radiology · 64d
Cleared Dec 13, 2000
GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
K003195 · SCL
Greer Laboratories, Inc.
General Hospital · 62d