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
69505–69528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444 · LNH
General Electric Co.
Radiology · 85d
Cleared Apr 14, 2004
ACELL UBM SURGICAL MESH
K040621 · FTM
Acell, Inc.
General & Plastic Surgery · 36d
Cleared Apr 14, 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
K040787 · OTN
Boston Scientific
Gastroenterology & Urology · 16d
Cleared Apr 14, 2004
FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES
K040793 · LYY
Hl Rubber Products Sdn Bhd
General Hospital · 16d
Cleared Apr 14, 2004
TERATECH MODEL 10V5 SMART PROBE
K040840 · ITX
Teratech Corp.
Radiology · 13d
Cleared Apr 13, 2004
TELECARE D.R. SERVER SOFTWARE SYSTEM
K033133 · MWI
Healthcare Vision, Inc.
Cardiovascular · 196d
Cleared Apr 13, 2004
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
K033710 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Apr 13, 2004
ORTHOCORD SUTURE
K040004 · NEW
Depuy Mitek
General & Plastic Surgery · 102d
Cleared Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342 · KRD
Boston Scientific Corp
Cardiovascular · 61d
Cleared Apr 13, 2004
E-Z SCAN AB5500+
K040668 · IYO
Sonomed, Inc.
Radiology · 29d
Cleared Apr 12, 2004
TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
K031310 · IPF
Tai Sheng Electrical Machinery Co., Ltd.
Physical Medicine · 354d
Cleared Apr 12, 2004
MEDSAFE SYSTEM INSERTER
K032848 · KZH
Medsolve Technologies, LLC
General Hospital · 213d
Cleared Apr 12, 2004
OPTI-RIDER DELUXE
K033116 · INI
Hansung Econet Co., Ltd.
Physical Medicine · 195d
Cleared Apr 12, 2004
ART ANTERIOR SPINAL SYSTEM
K033148 · KWQ
Advanced Medical Technologies AG
Orthopedic · 195d
Cleared Apr 12, 2004
TALON INFUSION SET, MODEL IP XXXX
K033290 · FPA
Icu Medical, Inc.
General Hospital · 181d
Cleared Apr 12, 2004
NUVASIVE SPINAL SYSTEM
K033546 · MNH
Nuvasive, Inc.
Orthopedic · 152d
Cleared Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · MBH
Howmedica Osteonics Corp.
Orthopedic · 112d
Cleared Apr 12, 2004
MFCD 2320
K040158 · LLZ
Barco N.V.
Radiology · 80d
Cleared Apr 12, 2004
VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS)
K040285 · IMG
Chattanooga Group
Physical Medicine · 66d
Cleared Apr 12, 2004
QUIESCENCE
K040330 · KLW
Spectral Visualization & Development,...
Ear, Nose, Throat · 61d
Cleared Apr 12, 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · HSB
Synthes (Usa)
Orthopedic · 61d
Cleared Apr 12, 2004
CERAMIC TIPPED SKULL PIN
K040363 · LYT
The Jerome Group, Inc.
Orthopedic · 59d
Cleared Apr 12, 2004
LANX ANTERIOR CERVIAL PLATE SYSTEM
K040401 · KWQ
Lanx, LLC
Orthopedic · 55d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · HRS
Zimmer, Inc.
Orthopedic · 35d