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
71545–71568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2003
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
K032212 · HRX
Kyphon, Inc.
Orthopedic · 56d
Cleared Sep 15, 2003
PRISMA M60/M100 SETS
K032431 · KDI
Gambro, Inc.
Gastroenterology & Urology · 40d
Cleared Sep 15, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
K032518 · JWY
Bd Diagnostic Systems
Microbiology · 32d
Cleared Sep 15, 2003
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K032566 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 12, 2003
HANDYDOP
K030466 · KNG
Elcat, GmbH
Radiology · 212d
Cleared Sep 12, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K030522 · LPN
Ciba Vision Corporation
Ophthalmic · 205d
Cleared Sep 12, 2003
THERMOSKIN CONDUCTIVE PADS
K030564 · GXY
United Pacific, Inc.
Neurology · 203d
Cleared Sep 12, 2003
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
K030961 · LHD
Microlife Corp.
Obstetrics & Gynecology · 169d
Cleared Sep 12, 2003
S-MONOVETTE EDTA K2-GEL
K031359 · PJE
Sarstedt, Inc.
Chemistry · 135d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d
Cleared Sep 12, 2003
SAFETY-MULTIFLY
K032150 · FPA
Sarstedt, Inc.
General Hospital · 60d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 12, 2003
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
K032229 · ILY
Quantum Devices, Inc.
Physical Medicine · 53d
Cleared Sep 12, 2003
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · FMG
Elcam Medical Acal
General Hospital · 39d
Cleared Sep 12, 2003
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K032538 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 12, 2003
POLESTAR N-20
K032541 · LNH
Odin Medical Technologies , Ltd.
Radiology · 25d
Cleared Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Sep 12, 2003
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
K032588 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 21d
Cleared Sep 12, 2003
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
K032618 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Sep 12, 2003
RS-4I MUSCLE STIMULATOR FAMILY
K032652 · IPF
Rs Medical
Physical Medicine · 15d
Cleared Sep 12, 2003
E275
K032653 · GZJ
Micro Current Technology, Inc.
Neurology · 15d
Cleared Sep 12, 2003
VORTEX MP
K032754 · LJT
Horizon Medical Products, Inc.
General Hospital · 7d
Cleared Sep 11, 2003
LATEX ULTRASONIC PROBE COVER
K022156 · ITX
Pleasure Latex Products Sdn. Bhd.
Radiology · 436d
Cleared Sep 11, 2003
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
K022258 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 426d