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
72961–72984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2003
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
K023915 · LYY
Sanrea Healthcare Private Limited
General Hospital · 78d
Cleared Feb 11, 2003
MARK I THERMAL IMAGER
K023925 · LHQ
Ix-Dr, Inc.
Radiology · 78d
Cleared Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · JHI
Bayer Corp.
Chemistry · 77d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · JJX
Wako Chemicals USA, Inc.
Toxicology · 35d
Cleared Feb 11, 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · KPS
General Electric Co.
Radiology · 21d
Cleared Feb 11, 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 12d
Cleared Feb 10, 2003
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
K021153 · HEX
Goldway Us, Inc.
Obstetrics & Gynecology · 306d
Cleared Feb 10, 2003
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K022856 · GEI
Aaron Medical Industries
General & Plastic Surgery · 167d
Cleared Feb 10, 2003
ACON STREP A TWIST TEST DEVICE
K023766 · GTY
Acon Laboratories Co.
Microbiology · 90d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Microgenics Corp.
Toxicology · 90d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Feb 10, 2003
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER,...
K023800 · JOW
Aircast, Inc.
Cardiovascular · 88d
Cleared Feb 10, 2003
POLARIS DS
K024064 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Feb 10, 2003
ALLON 2001 VERSION 5
K024128 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 56d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Feb 10, 2003
THOR DDII 830CL3 LASER SYSTEM
K030226 · NHN
Thor Intl.
Physical Medicine · 19d
Cleared Feb 10, 2003
NOBEL PERFECT IMPLANT SYSTEM
K030257 · DZE
Nobel Biocare Uas, Inc.
Dental · 17d
Cleared Feb 07, 2003
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
K022696 · ITI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 178d
Cleared Feb 07, 2003
W & H LISA STEAM STERILIZER
K022816 · FLE
A-Dec, Inc.
General Hospital · 165d
Cleared Feb 07, 2003
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · BTM
Nellcor Puritan Bennett, Inc.
Anesthesiology · 112d
Cleared Feb 07, 2003
BD INTEGRA SYRINGE
K023752 · FMF
Bd
General Hospital · 91d
Cleared Feb 07, 2003
SOHNIKS
K023783 · HRX
Sohniks Endoscopy, Inc.
Orthopedic · 87d
Cleared Feb 07, 2003
AUTOMED 3000 INFUSION PUMP
K023863 · FRN
Help Technologies
General Hospital · 79d
Cleared Feb 07, 2003
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K023868 · HAE
Dannoritzer Medical Instruments
Neurology · 79d