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
59065–59088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2007
MECHANICAL WHEELCHAIR - L-FRAME SERIES
K071444 · IOR
Colours 'N Motion
Physical Medicine · 64d
Cleared Jul 27, 2007
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
K071821 · GWF
Tonica Elektronik A/S
Neurology · 24d
Cleared Jul 27, 2007
SYNGO TRUED
K071950 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 26, 2007
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
K061914 · NGX
Sport-Elec S.A.
Physical Medicine · 385d
Cleared Jul 26, 2007
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
K063495 · OAT
Biomaterials Korea, Inc.
Dental · 248d
Cleared Jul 26, 2007
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
K070598 · HTY
Memometal Technologies
Orthopedic · 146d
Cleared Jul 26, 2007
PSI BANDS
K070766 · MVV
Psi Health Solutions, Inc.
Neurology · 128d
Cleared Jul 26, 2007
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH...
K071060 · LYY
Sgmp Co., Ltd.
General Hospital · 101d
Cleared Jul 26, 2007
DEMI
K071251 · EBZ
Kerr Corporation
Dental · 83d
Cleared Jul 26, 2007
MODEL SEGAEGO 3D SCOOTER
K071284 · INI
Dalton Medical Corp.
Physical Medicine · 80d
Cleared Jul 26, 2007
BIOMET VARIABLE LOCKING PLATE SYSTEM
K071325 · HRS
Biomet Trauma
Orthopedic · 77d
Cleared Jul 26, 2007
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
K071503 · KPS
Syntermed, Inc.
Radiology · 55d
Cleared Jul 26, 2007
ANEUROPLASTIC, MODEL 43-1290
K071776 · JXH
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Jul 26, 2007
PORTRAIT PSR
K071786 · GEI
Rhytec Incorporated
General & Plastic Surgery · 24d
Cleared Jul 26, 2007
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
K071819 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 23d
Cleared Jul 25, 2007
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
K053613 · FRO
Theo Manufacturing BV
General & Plastic Surgery · 575d
Cleared Jul 25, 2007
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
K063427 · GEX
Lynton Lasers Limited
General & Plastic Surgery · 254d
Cleared Jul 25, 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 188d
Cleared Jul 25, 2007
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
K070737 · JEY
Prosurg, Inc.
Dental · 131d
Cleared Jul 25, 2007
UNO
K071131 · KLE
3M Espe AG Dental Products
Dental · 93d
Cleared Jul 25, 2007
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
K071174 · NKB
Abbott Spine, Inc.
Orthopedic · 89d
Cleared Jul 25, 2007
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
K071209 · LYY
High Momentum Sdn Bhd
General Hospital · 85d
Cleared Jul 25, 2007
MICROTARGETING GUIDELINE 4000
K071364 · GZL
FHC, Inc.
Neurology · 70d
Cleared Jul 25, 2007
CERMET III ACETABULAR CUP SYSTEM
K071583 · MEH
Implants International, Ltd.
Orthopedic · 47d