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

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176,076 results
81289–81312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 11, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K001550 · LLZ
Imatron, Inc.
Radiology · 207d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956 · JDI
Howmedica Osteonics Corp.
Orthopedic · 167d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · HKX
Xomed, Inc.
Ophthalmic · 126d
Cleared Dec 11, 2000
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K002616 · INI
Electric Mobility Corp.
Physical Medicine · 111d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · LPH
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 11, 2000
MERIT DRAINAGE DEPOT
K003078 · EXF
Merit Medical Systems, Inc.
Gastroenterology & Urology · 69d