FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68161–68184 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 2004
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · JDS
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · JDW
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · LON
Becton, Dickinson & CO
Microbiology · 171d
Cleared Apr 09, 2004
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
K033397 · DXN
Avita Corporation
Cardiovascular · 168d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K033907 · LON
Becton, Dickinson & CO
Microbiology · 114d
Cleared Apr 09, 2004
FINE SURGICAL CIRCUMCISION CLAMP
K040052 · HFX
Fine Surgical Instrument Corp.
Obstetrics & Gynecology · 88d
Cleared Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
K040056 · MKJ
Bio-Detek, Inc.
Cardiovascular · 87d
Cleared Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
K040256 · MKJ
Bio-Detek, Inc.
Cardiovascular · 65d