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
80161–80184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 12, 2000
OPUS 20, MODEL 1ST
K002899 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 85d
Cleared Dec 12, 2000
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
K002970 · JXG
Medical Designs, LLC
Neurology · 81d
Cleared Dec 12, 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K003201 · HAW
Medtronic Surgical Navigation...
Neurology · 61d
Cleared Dec 12, 2000
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
K003249 · GEI
Pst, Inc.
General & Plastic Surgery · 56d
Cleared Dec 12, 2000
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · FRN
Baxter Healthcare Corp
General Hospital · 20d
Cleared Dec 12, 2000
LEIBINGER NEURO CLIP SYSTEM
K003660 · JEY
Stryker Instruments
Dental · 14d
Cleared Dec 11, 2000
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
K000249 · FIP
Schaefer Water Centers
Gastroenterology & Urology · 319d
Cleared Dec 11, 2000
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851 · DJG
Psychemedics Corp.
Toxicology · 271d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160 · LOD
Smith & Nephew, Inc.
Orthopedic · 245d