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
66217–66240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2005
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K050181 · KGO
Medigloves , Ltd.
General Hospital · 76d
Cleared Apr 13, 2005
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
K050433 · FRN
Zimmer Orthopaedic Surgical Products
General Hospital · 50d
Cleared Apr 13, 2005
JSZ-MULTIPURPOSE SOLUTION
K050517 · LPN
Szabocsik and Associates
Ophthalmic · 43d
Cleared Apr 13, 2005
AQUAFLEX 2 (TEFILCON) CONTACT LENS
K050743 · LPL
Unilens Corp., USA
Ophthalmic · 23d
Cleared Apr 13, 2005
TELEREHAD 2004
K050778 · DRG
Scottcare
Cardiovascular · 16d
Cleared Apr 12, 2005
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · LJN
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Apr 12, 2005
OSOM HCG COMBO TEST
K043385 · JHI
Genzyme Diagnostics
Chemistry · 124d
Cleared Apr 12, 2005
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · MQN
Synthes (Usa)
Dental · 106d
Cleared Apr 12, 2005
REPROCESSED HARMONIC SCALPELS
K050343 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 60d
Cleared Apr 12, 2005
EVADRI BLADDER CONTROL SYSTEMS
K050483 · KPI
Hollister, Inc.
Gastroenterology & Urology · 47d
Cleared Apr 12, 2005
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
K050676 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Apr 12, 2005
AURORA DS, DS APPLICATOR
K050796 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 14d
Cleared Apr 12, 2005
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
K050831 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 11d
Cleared Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565 · LPH
Ortho Development Corp.
Orthopedic · 202d
Cleared Apr 11, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · KWP
Medtronic Sofamor Danek
Orthopedic · 157d
Cleared Apr 11, 2005
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
K050193 · MSH
Louis M. Gerson Co., Inc.
General Hospital · 74d
Cleared Apr 11, 2005
AXS-1 LITE WHEELCHAIR
K050279 · IOR
Access Point Medical, LLC
Physical Medicine · 63d
Cleared Apr 11, 2005
RUNABOUT WHEELCHAIR
K050280 · IOR
Access Point Medical, LLC
Physical Medicine · 63d
Cleared Apr 11, 2005
TRANSPORT SERIES TRANSPORT CHAIR
K050281 · IOR
Access Point Medical, LLC
Physical Medicine · 63d
Cleared Apr 11, 2005
PLIX
K050414 · BYJ
Respironics, Inc.
Anesthesiology · 52d
Cleared Apr 11, 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490 · MQV
Medicrea
Orthopedic · 45d
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · HRS
Synthes (Usa)
Orthopedic · 32d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · MQP
Stryker Spine
Orthopedic · 31d
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · LXT
Synthes (Usa)
Orthopedic · 31d