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
56209–56232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2008
ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
K080972 · GDW
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 90d
Cleared Jul 03, 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · MNI
Alphatec Spine, Inc.
Orthopedic · 71d
Cleared Jul 03, 2008
EVOLVE EPS SYSTEM
K081373 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 48d
Cleared Jul 03, 2008
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · KWQ
Globus Medical, Inc.
Orthopedic · 45d
Cleared Jul 03, 2008
VERTEBRON SSP CERVICAL PLATING SYSTEM
K081567 · KWQ
Vertebron, Inc.
Orthopedic · 29d
Cleared Jul 03, 2008
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200)...
K081598 · MBI
Kfx Medical
Orthopedic · 27d
Cleared Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS,...
K081643 · MMI
Siemens Healthcare Diagnostics
Chemistry · 21d
Cleared Jul 03, 2008
SYNGO IMAGING (VERSION V31)
K081734 · LLZ
Siemens AG Medical Solutions
Radiology · 14d
Cleared Jul 02, 2008
MYKRES SPINAL SYSTEM
K071074 · MNI
Showa Ika Kohgyo Co., Ltd.
Orthopedic · 443d
Cleared Jul 02, 2008
ELECTRODE ARRAY CAP
K071446 · GXY
Electrode Arrays
Neurology · 405d
Cleared Jul 02, 2008
ORTHOBIOM SPINAL SYSTEM
K071668 · MNI
Paradigm Spine
Orthopedic · 379d
Cleared Jul 02, 2008
LAGUNA SIZE 8 PEDICLE SCREW
K072678 · NKB
Allez Spine, LLC
Orthopedic · 285d
Cleared Jul 02, 2008
NORIAN DRILLABLE
K073303 · OIS
Synthes (Usa)
Orthopedic · 222d
Cleared Jul 02, 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 147d
Cleared Jul 02, 2008
VU APOD INTERVERTABRAL BODY FUSION DEVICE
K080822 · OVD
Theken Spine, LLC
Orthopedic · 100d
Cleared Jul 02, 2008
SPINESMITH CIMPLICITY SPINAL SYSTEM
K080971 · MQP
Spine Smith Partners L.P.
Orthopedic · 89d
Cleared Jul 02, 2008
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
K080991 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 02, 2008
WRIST PULSE OXIMETER MD300W
K081125 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 72d
Cleared Jul 02, 2008
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · JHM
Siemens Healthcare Diagnostics
Chemistry · 55d
Cleared Jul 02, 2008
RELIANCE VBS SYSTEM
K081383 · MQP
Reliance Medical Systems, LLC
Orthopedic · 47d
Cleared Jul 02, 2008
SOLITAIRE ANTERIOR SPINAL SYSTEM
K081501 · OVD
Biomet Spine
Orthopedic · 34d
Cleared Jul 02, 2008
INTEGRE PRO, MODEL L2RY
K081565 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 28d
Cleared Jul 02, 2008
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
K081597 · MNI
Vertebron, Inc.
Orthopedic · 26d
Cleared Jul 02, 2008
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
K081609 · CGA
Taidoc Technology Corporation
Chemistry · 23d