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
89953–89976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1998
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · KWL
Osteonics Corp.
Orthopedic · 83d
Cleared Mar 16, 1998
CSR
K974865 · EBI
Parkell, Inc.
Dental · 77d
Cleared Mar 16, 1998
EXTERNAL FIXATOR
K974911 · JDW
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Mar 16, 1998
ACUMED SUTURE ANCHOR
K980103 · MBI
Acu Med, Inc.
Orthopedic · 63d
Cleared Mar 16, 1998
DIO-LIGHT LASER SYSTEM
K980201 · GEX
Nidek, Inc.
General & Plastic Surgery · 55d
Cleared Mar 16, 1998
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT...
K980331 · DIF
More Diagnostics
Toxicology · 47d
Cleared Mar 16, 1998
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
K980430 · GXI
Radionics, Inc.
Neurology · 40d
Cleared Mar 16, 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · DZE
Steri-Oss, Inc.
Dental · 40d
Cleared Mar 16, 1998
CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM
K980442 · DZE
Crystal Medical Technology
Dental · 40d
Cleared Mar 16, 1998
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
K980582 · DSA
Marquette Medical Systems, Inc.
Cardiovascular · 27d
Cleared Mar 16, 1998
NITRILE EXAM GLOVE, POWDER FREE
K980677 · LZA
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 24d
Cleared Mar 13, 1998
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM...
K971591 · LSQ
David C. Bishop, Ph.D.
Microbiology · 316d
Cleared Mar 13, 1998
MS-700
K972213 · DPW
Alan S. Lee
Cardiovascular · 274d
Cleared Mar 13, 1998
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
K972749 · HQR
C.M. Chance , Ltd.
Ophthalmic · 233d
Cleared Mar 13, 1998
CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
K973061 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 207d
Cleared Mar 13, 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 185d
Cleared Mar 13, 1998
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL...
K973474 · MHX
Witt Biomedical Corporation
Cardiovascular · 182d
Cleared Mar 13, 1998
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
K973628 · JJF
Vital Scientific N.V.
Chemistry · 170d
Cleared Mar 13, 1998
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
K973664 · LYY
Evergrade Healthcare Products Sdn Bhd
General Hospital · 169d
Cleared Mar 13, 1998
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
K974009 · JHI
International Newtech Development, Inc.
Chemistry · 143d
Cleared Mar 13, 1998
SMARTTEX
K974557 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 98d
Cleared Mar 13, 1998
COAXIAL DILATOR SET
K974640 · DRE
Boston Scientific Corp
Cardiovascular · 88d
Cleared Mar 13, 1998
COMBICATH CATHETER
K974642 · EOQ
Plastimed Laboratoire Pharmaceutique
Ear, Nose, Throat · 88d
Cleared Mar 13, 1998
SILICONE ELASTOMER SHEETING
K974653 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 88d