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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94417–94440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1997
UHE COLLIMATOR (210591)
K963406 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 181d
Cleared Feb 26, 1997
GALILEO EVOKED POTENTIALRE
K963662 · GWF
Biosound, Inc.
Neurology · 166d
Cleared Feb 26, 1997
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
K964018 · HQC
Michael Reynard, M.D.
Ophthalmic · 142d
Cleared Feb 26, 1997
BERENSTEIN COIL
K964112 · KRD
Target Therapeutics
Cardiovascular · 134d
Cleared Feb 26, 1997
SPONGETRAC
K964181 · MRL
Surgitrac Corp.
General Hospital · 131d
Cleared Feb 26, 1997
VIPOR UNIT
K964322 · JAA
Tilane Corp.
Radiology · 120d
Cleared Feb 26, 1997
BARD DIRECTOR GUIDEWIRE (000560)
K964780 · OCY
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 26, 1997
SPETEMP
K964808 · EMA
Ultradent Products, Inc.
Dental · 89d
Cleared Feb 26, 1997
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K964813 · MOS
Medical Advances, Inc.
Radiology · 89d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990 · JAA
Hitachi Medical Systems America, Inc.
Radiology · 72d
Cleared Feb 26, 1997
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · FPK
Medtronic Minimed
General Hospital · 61d
Cleared Feb 26, 1997
ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
K970039 · GEI
Medtrex, Inc.
General & Plastic Surgery · 51d
Cleared Feb 26, 1997
AHS OMEGA SP
K970057 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 50d
Cleared Feb 26, 1997
PM 2002 CC PROLINE
K970263 · EHD
Planmeca Oy
Radiology · 34d
Cleared Feb 25, 1997
RESPIFLO
K962872 · CAF
Tyco Healthcare Deutschaland GmbH
Anesthesiology · 217d
Cleared Feb 25, 1997
RESPIFLO/S
K962874 · CAF
Curtin & Associates International , Inc.
Anesthesiology · 217d
Cleared Feb 25, 1997
CAPIOX SP PUMP HEAD
K962981 · KFM
Terumo Medical Corp.
Cardiovascular · 208d
Cleared Feb 25, 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · KTN
Genzyme Diagnostics
Immunology · 179d
Cleared Feb 25, 1997
MASK SURGICAL
K963568 · FXX
The Innovative Approach, Corp.
General Hospital · 173d
Cleared Feb 25, 1997
EZTEST
K963841 · FRC
Sgm Biotech, Inc.
General Hospital · 153d
Cleared Feb 25, 1997
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
K963917 · CAF
Holden Walker Corp.
Anesthesiology · 148d
Cleared Feb 25, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · GEH
Endocare, Inc.
General & Plastic Surgery · 145d
Cleared Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · KKX
Medline Industries, Inc.
General Hospital · 132d
Cleared Feb 25, 1997
DISPOSABLE APRON
K964364 · LYU
Instrument Makar, Inc.
General Hospital · 116d