FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
43369–43392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2012
SONY PVM-2551MD OLED MONITOR
K120611 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 120d
Cleared Jun 28, 2012
FIBEROPTIC LASER DELIVERY SYSTEM
K120810 · GEX
Fiberoptic Fabrications, Inc.
General & Plastic Surgery · 104d
Cleared Jun 28, 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · MAX
Nuvasive, Inc.
Orthopedic · 93d
Cleared Jun 28, 2012
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92...
K120996 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
K121087 · NBW
Bayer Healthcare
Chemistry · 79d
Cleared Jun 28, 2012
WI-FI BODY SCALE
K121527 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 36d
Cleared Jun 27, 2012
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 286d
Cleared Jun 27, 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · OBR
Oralabs, Inc.
Dental · 230d
Cleared Jun 27, 2012
DATACAPTOR SYSTEM
K113835 · MWI
Capsule Tech, Inc.
Cardiovascular · 183d
Cleared Jun 27, 2012
GAM-200
K120243 · EMA
GC America, Inc.
Dental · 152d
Cleared Jun 27, 2012
DR GREENBURGS HYBRID ACRYLIC
K120371 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
DR GREENBURGS HYBRID VACUUM
K120372 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
LDR SPINE SPINETUNE TL SPINAL SYSTEM
K120760 · MNH
Ldr Spine USA, Inc.
Orthopedic · 106d
Cleared Jun 27, 2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
K120780 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jun 27, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · MNH
K2m, Inc.
Orthopedic · 84d
Cleared Jun 27, 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · KWQ
Globus Medical, Inc.
Orthopedic · 82d
Cleared Jun 27, 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K121211 · OVD
Theken Spine, LLC
Orthopedic · 68d
Cleared Jun 27, 2012
PIXEL APP
K121274 · LWH
Gauss Surgical, Inc.,
General & Plastic Surgery · 61d
Cleared Jun 27, 2012
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jun 27, 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
K121522 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 35d
Cleared Jun 26, 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
K111369 · CFF
Helena Laboratories Uk, Ltd.
Immunology · 407d
Cleared Jun 26, 2012
SYS*STIM 240
K113017 · IPF
Mettler Electronics Corp.
Physical Medicine · 259d
Cleared Jun 26, 2012
XTRAFIX EXTERNAL FIXATION SYSTEM
K113383 · KTT
Extraortho, Inc.
Orthopedic · 223d
Cleared Jun 26, 2012
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
K120002 · KNW
Busse Hospital Disposables, Inc.
Gastroenterology & Urology · 175d