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
59041–59064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2007
ENDODRAPE
K070406 · KKX
Vortek Surgical, LLC
General Hospital · 168d
Cleared Jul 30, 2007
A-VIEW BASIC AND PLUS
K070515 · ITX
Cordatec N.V.
Radiology · 158d
Cleared Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · KQO
ACON Laboratories, Inc.
Chemistry · 118d
Cleared Jul 30, 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · MQP
Theken Spine, LLC
Orthopedic · 110d
Cleared Jul 30, 2007
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
K071105 · HRS
Osteomed LP
Orthopedic · 102d
Cleared Jul 30, 2007
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K071123 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 98d
Cleared Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · IKT
Ambu A/S
Neurology · 91d
Cleared Jul 30, 2007
ZEO CE LIGHT & ZEO QUICK PORCELAIN
K071201 · EIH
Xpdent Corp
Dental · 91d
Cleared Jul 30, 2007
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
K071208 · LZA
High Momentum Sdn Bhd
General Hospital · 90d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211 · CIT
Roche Diagnostics
Chemistry · 90d
Cleared Jul 30, 2007
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
K071212 · CBK
Respironics California, Inc.
Anesthesiology · 90d
Cleared Jul 30, 2007
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
K071571 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 52d
Cleared Jul 30, 2007
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
K071587 · JJX
Inverness Medical Innovations, Inc.
Chemistry · 49d
Cleared Jul 30, 2007
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · GXP
Codman & Shurtleff, Inc.
Neurology · 28d
Cleared Jul 30, 2007
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S)...
K071856 · KWA
Zimmer, Inc.
Orthopedic · 25d
Cleared Jul 30, 2007
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
K071972 · LLZ
Agfa Healthcare Corp.
Radiology · 13d
Cleared Jul 30, 2007
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
K072000 · IYN
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Jul 27, 2007
SPINAL SPHERES
K062992 · NVR
Interbody Innovations, Llp
Orthopedic · 298d
Cleared Jul 27, 2007
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03...
K063275 · HRS
Terray Corp.
Orthopedic · 270d
Cleared Jul 27, 2007
D-LINE CATHETER ST, DOUBLE LUMEN ST
K063355 · MPB
Novosci Corp.
Gastroenterology & Urology · 262d
Cleared Jul 27, 2007
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
K063757 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 220d
Cleared Jul 27, 2007
MODIFICATION TO VELASMOOTH, SHAPER
K070092 · NUV
Syneron Medical, Ltd.
General & Plastic Surgery · 198d
Cleared Jul 27, 2007
ENDOCERVICAL ELECTRODE # 2
K070877 · HGI
Modern Medical Equipment Mfg., Ltd.
Obstetrics & Gynecology · 120d
Cleared Jul 27, 2007
MODEL SEGAEGO 4D SCOOTER
K071282 · INI
Dalton Medical Corp.
Physical Medicine · 81d