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
74185–74208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296 · KWP
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Dec 10, 2002
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · MNH
Sintea Biotech, Inc.
Orthopedic · 334d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · GQG
Becton, Dickinson & CO
Microbiology · 162d
Cleared Dec 10, 2002
SNORE-AID MAX
K022284 · LRK
Dental Imagineers, LLC
Dental · 148d
Cleared Dec 10, 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...
K022377 · KWT
Implex Corp.
Orthopedic · 141d
Cleared Dec 10, 2002
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
K023019 · FGI
Vomed Volzer Medizintechnik GmbH & Co.
Gastroenterology & Urology · 90d
Cleared Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
K023077 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 85d
Cleared Dec 10, 2002
SMARTSTEP SYSTEM
K023161 · IRN
Andante Medical Device, Ltd.
Physical Medicine · 78d
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320 · DQY
Guidant Corp.
Cardiovascular · 67d
Cleared Dec 10, 2002
BIOPORTA G
K023391 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 62d
Cleared Dec 10, 2002
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
K023469 · FPA
Victus, Inc.
General Hospital · 55d
Cleared Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K023732 · LPL
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 10, 2002
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · JIX
Ortho-Clinical Diagnostics, Inc.
Toxicology · 19d
Cleared Dec 09, 2002
AAP CANNULATED SCREWS
K021233 · HWC
Aap Implantate AG
Orthopedic · 235d
Cleared Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · HAW
Smith & Nephew, Inc.
Neurology · 192d
Cleared Dec 09, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH...
K022313 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 145d
Cleared Dec 09, 2002
INSTANT-VIEW TCA URINE TEST
K022693 · MLK
Alfa Scientific Designs, Inc.
Toxicology · 118d
Cleared Dec 09, 2002
ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
K023098 · MEB
Mckinley Infuser
General Hospital · 82d
Cleared Dec 09, 2002
AMSINO TRACHEOSTOMY CARE TRAY
K023276 · LRO
Amsino International, Inc.
General & Plastic Surgery · 69d
Cleared Dec 09, 2002
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN,...
K023304 · JKR
Diagnostic Products Corp.
Chemistry · 67d