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
55705–55728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2008
NUTRITONE FACIAL BEAUTY SYSTEM
K070250 · NFO
Isomers Laboratories, Inc.
Neurology · 587d
Cleared Sep 04, 2008
MICARDIA ANNULOPLASTY BAND DR
K070488 · KRH
Micardia Corporation
Cardiovascular · 562d
Cleared Sep 04, 2008
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · ELC
Sybron Dental Specialties, Inc.
Dental · 234d
Cleared Sep 04, 2008
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
K080412 · GAM
Shanghai Pudong Jinhuan Medical...
General & Plastic Surgery · 202d
Cleared Sep 04, 2008
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K080992 · HRS
Aesculap Implant Systems, Inc.
Orthopedic · 150d
Cleared Sep 04, 2008
VEO MULTIGAS MONITOR FOR POCKET PC
K081601 · CCK
Phasein AB
Anesthesiology · 90d
Cleared Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES,...
K082206 · EWL
Helix Medical, LLC
Ear, Nose, Throat · 30d
Cleared Sep 04, 2008
BLACKSTONE PILLAR XL PEEK SPACERS
K082235 · MAX
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Sep 03, 2008
STARLIGHT, MODEL PD9012
K073317 · GEX
F.P. Rubinstein Y Cia S.R.L.
General & Plastic Surgery · 282d
Cleared Sep 03, 2008
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · EFB
Sybron Dental Specialties, Inc.
Dental · 267d
Cleared Sep 03, 2008
OLYMPUS TOTAL BHCG TEST SYSTEN
K080094 · DHA
Olympus Life Science Research Europa...
Chemistry · 233d
Cleared Sep 03, 2008
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
K080473 · MQL
Medicult A/S
Obstetrics & Gynecology · 195d
Cleared Sep 03, 2008
MS SYSTEM (NARROW RIDGE)
K080594 · DZE
Osstem Implant Co., Ltd.
Dental · 184d
Cleared Sep 03, 2008
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · FYA
Kimberly-Clark Corp.
General Hospital · 167d
Cleared Sep 03, 2008
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K081042 · NEY
Bsd Medical Systems Corp.
General & Plastic Surgery · 145d
Cleared Sep 03, 2008
RE-ZORB PLATING SYSTEM
K081588 · HRS
Acute Innovations, LLC
Orthopedic · 90d
Cleared Sep 03, 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005,...
K081758 · MQV
Depuy Spine, Inc.
Orthopedic · 75d
Cleared Sep 03, 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND...
K081907 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 62d
Cleared Sep 03, 2008
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · MMK
Zhejiang Gongdong Medical Plastic...
General Hospital · 47d
Cleared Sep 03, 2008
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS...
K082141 · JIT
Biokit, S.A.
Chemistry · 35d
Cleared Sep 03, 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Sep 02, 2008
RMX PHYSIOLOGICAL DATA RECORDER
K080375 · MNR
S.L.P. , Ltd.
Anesthesiology · 203d
Cleared Sep 02, 2008
RESERT XL HLD HIGH LEVEL DISINFECTANT
K080420 · MED
STERIS Corporation
General Hospital · 200d
Cleared Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER,...
K080711 · KGI
Hologic, Inc.
Radiology · 173d