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
90457–90480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1998
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
K980118 · LLZ
Eastman Kodak Company
Radiology · 63d
Cleared Mar 17, 1998
DI-2000
K980213 · LMA
Lumisys, Inc.
Radiology · 67d
Cleared Mar 17, 1998
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE
K980241 · LMD
Netco Communications Corp.
Radiology · 53d
Cleared Mar 17, 1998
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K980247 · HDC
Gynex Corp.
Obstetrics & Gynecology · 53d
Cleared Mar 16, 1998
OSMO/PCA PILLOW WOUND DRESSING
K971612 · KMF
Procyte Corp.
General & Plastic Surgery · 318d
Cleared Mar 16, 1998
AMPLAID MK12
K971740 · GWF
Amplifon S.P.A.
Neurology · 308d
Cleared Mar 16, 1998
ZOLL REVIVER
K972241 · MKJ
Zoll Medical Corp
Cardiovascular · 273d
Cleared Mar 16, 1998
ORION ANTERIOR CERVICAL PLATE SYSTEM
K973854 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 164d
Cleared Mar 16, 1998
SYNTHES CRANIAL SPRING CLIP (CSC)
K974206 · GWO
Synthes (Usa)
Neurology · 126d
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