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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
36169–36192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2015
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
K140893 · JOZ
Coramed Technologies, LLC
Hematology · 270d
Cleared Jan 02, 2015
ZX-27
K133088 · EJX
M&M Dental Studio, Inc.
Dental · 459d
Cleared Jan 02, 2015
FIREBIRD SPINAL FIXATION SYSTEM
K141186 · NKB
Orthofix, Inc.
Orthopedic · 240d
Cleared Jan 02, 2015
NAVILAS LASER SYSTEM
K141851 · GEX
Od-Os GmbH
General & Plastic Surgery · 177d
Cleared Jan 02, 2015
Laparoscopic FMsealer
K142229 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 142d
Cleared Jan 02, 2015
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
K143154 · GEX
Iridex Corporation
General & Plastic Surgery · 60d
Cleared Jan 02, 2015
TE7 Diagnostic Ultrasound System
K143472 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Dec 31, 2014
UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM...
K133333 · OMP
Blue Ocean Medical Product, LLC
General & Plastic Surgery · 428d
Cleared Dec 31, 2014
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K142124 · EKX
Aseptico, Inc.
Dental · 149d
Cleared Dec 31, 2014
PK Spatula
K142289 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 135d
Cleared Dec 31, 2014
TYRX Neuro Absorbable Antibacterial Envelope
K142611 · FTL
Medtronic Tyrx, Inc.
General & Plastic Surgery · 106d
Cleared Dec 31, 2014
LITe Plate System
K142699 · KWQ
Stryker Corporation
Orthopedic · 100d
Cleared Dec 31, 2014
AEx Generator
K143175 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 57d
Cleared Dec 30, 2014
OWL CANNULAE
K141586 · GXI
Diros Technology, Inc.
Neurology · 200d
Cleared Dec 30, 2014
ACROSSPINE PEDICLE SCREW SYSTEM
K141695 · NKB
Arthro-Dif
Orthopedic · 189d
Cleared Dec 30, 2014
TRIA FANP
K141868 · ONG
Tria Beauty, Inc.
General & Plastic Surgery · 173d
Cleared Dec 30, 2014
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173 · LHC
Ecolab, Inc.
General Hospital · 145d
Cleared Dec 30, 2014
3.Omm Biomet Cannulated Screw System
K143188 · HWC
Biomet Manufacturing Corp
Orthopedic · 55d
Cleared Dec 29, 2014
VECTRIX EXTERNAL FIXATOR
K140649 · NDK
3D Medical Concepts, LLC
Orthopedic · 291d
Cleared Dec 29, 2014
MICROBLAB, MICROLOOP
K141936 · BZG
Carefusion Germany 234 GmbH
Anesthesiology · 165d
Cleared Dec 29, 2014
G7 Finned Acetabular Shell
K142746 · LPH
Biomet Manufactuting Corp.
Orthopedic · 96d
Cleared Dec 29, 2014
AQUARIUS Gastrostomy Replacement Tube
K143378 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 34d
Cleared Dec 24, 2014
MIDI-SRS
K141046 · ONG
Srmc Co., Ltd.
General & Plastic Surgery · 245d
Cleared Dec 24, 2014
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141878 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 166d