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

Filters: Cleared only ×
175,820 results
46777–46800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2011
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
K110348 · OWI
Zimmer Spine
Orthopedic · 185d
Cleared Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663 · FTL
Sofradim Production
General & Plastic Surgery · 156d
Cleared Aug 11, 2011
ORIGIN ZIRCONIA
K110719 · EIH
B&D Dental Technologies
Dental · 149d
Cleared Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
K111108 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 113d
Cleared Aug 11, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · MNI
Spineart
Orthopedic · 112d
Cleared Aug 11, 2011
DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
K111282 · FLL
Starboard Medical, LLC
General Hospital · 97d
Cleared CT Aug 11, 2011
WILDCAT CATHETER
K111338 · PDU
Avinger, Inc.
Cardiovascular · 91d
Cleared Aug 11, 2011
INFILL GRAFT DELIVERY SYSTEM
K111632 · FMF
Pinnacle Spine Group, LLC
General Hospital · 59d
Cleared CT Aug 11, 2011
EMBRYOSCOPE
K111715 · MQG
Unisense Fertilitech A/S
Obstetrics & Gynecology · 52d
Cleared Aug 11, 2011
ANODIZED HEALING COLLAR
K111852 · NHA
Zimmer Dental, Inc.
Dental · 43d
Cleared Aug 11, 2011
NIO COLOR 2MP
K111991 · LLZ
Barco N.V.
Radiology · 29d
Cleared Aug 10, 2011
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K101533 · JPA
Tem Innovations GmbH
Hematology · 433d
Cleared Aug 10, 2011
RADIOLOGICAL IMAGE PROCESSING SYSTEM
K102078 · LLZ
VATECH Co., Ltd.
Radiology · 380d
Cleared Aug 10, 2011
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE /...
K103619 · LYZ
Shandong Blue Sail Innovation Co., Ltd.
General Hospital · 243d
Cleared Aug 10, 2011
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N...
K110137 · JFY
HORIBA ABX SAS
Chemistry · 204d
Cleared Aug 10, 2011
RALCO
K110856 · IZX
Ralco S.R.L.
Radiology · 135d
Cleared Aug 10, 2011
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING...
K111158 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 107d
Cleared Aug 10, 2011
C7 XR IMAGING SYSTEM
K111201 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 103d
Cleared Aug 10, 2011
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · HTO
Synthes USA Products, LLC
Orthopedic · 78d
Cleared Aug 10, 2011
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
K111963 · DQY
Bridgepoint Medical
Cardiovascular · 30d
Cleared Aug 10, 2011
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
K112180 · OWB
Infimed, Inc.
Radiology · 13d
Cleared Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN)...
K100015 · OVQ
Abbott Molecular, Inc.
Pathology · 582d
Cleared CT Aug 09, 2011
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
K101307 · NBW
Andon Medical Co., Ltd.
Chemistry · 456d
Cleared Aug 09, 2011
CYBOW READER, MODELS 300 & 720
K102188 · KQO
DFI Co., Ltd.
Chemistry · 371d