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
80665–80688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 13, 2000
ECAT PET SCANNER
K003241 · KPS
Cti Pet Systems, Inc.
Radiology · 57d
Cleared Dec 13, 2000
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · FPA
Sterling Medivations, Inc.
General Hospital · 55d
Cleared Dec 13, 2000
NEXAN SYSTEM, MODEL NX-300
K003520 · MWJ
Nexan, Ltd.
Cardiovascular · 28d
Cleared Dec 13, 2000
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Dec 13, 2000
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
K003611 · FRN
Breg, Inc.
General Hospital · 21d
Cleared Dec 12, 2000
SHENLING ACUPUNCTURE NEEDLES
K002411 · MQX
Shenling Medical Device Co., Ltd.
General Hospital · 127d
Cleared Dec 12, 2000
GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE...
K002569 · FMF
Malgam Ent., Inc.
General Hospital · 116d