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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94921–94944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1997
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
K964847 · LYY
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 86d
Cleared Feb 27, 1997
MR EXTENSION SET (001)
K964968 · FPA
University of Michigan
General Hospital · 77d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · HWC
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Feb 27, 1997
ARGI-SATIN OR OPTI0-STAR
K965216 · ELL
Argen Precious Metals, Inc.
Dental · 59d
Cleared Feb 27, 1997
3M QUIKPLUS SYSTEM
K970168 · EBG
3M Company
Dental · 42d
Cleared Feb 27, 1997
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · KWT
Intermedics Orthopedics
Orthopedic · 14d
Cleared Feb 26, 1997
SHE-LI TENS STIMULATOR MODEL SL-101 RX
K961809 · GZJ
Medi Consultants, Inc.
Neurology · 292d
Cleared Feb 26, 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 288d
Cleared Feb 26, 1997
LIFESHIELD BLUNT CANNULA
K963351 · FMI
Abbott Laboratories
General Hospital · 184d
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