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
89929–89952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1998
M1765A ECG MANAGER
K974746 · DPS
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Mar 18, 1998
AUTO-DRIVE BONE SCREW
K974785 · HWC
Osteomed Corp.
Orthopedic · 86d
Cleared Mar 18, 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · HRS
Synthes (Usa)
Orthopedic · 77d
Cleared Mar 18, 1998
ENDOPATH AND PROXIMATE LINEAR CUTTERS
K980023 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 72d
Cleared Mar 18, 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · JHI
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Mar 18, 1998
FONIX FP35 HEARING AID ANALYZER
K980377 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 44d
Cleared Mar 18, 1998
LYSONIX ASPIRATION PUMP
K980454 · BTA
Lysonix, Inc.
General & Plastic Surgery · 41d
Cleared Mar 17, 1998
CTS MIDCAB STITCHER
K963965 · GEI
Cardiothoracic Systems, Inc.
General & Plastic Surgery · 531d
Cleared Mar 17, 1998
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · DXE
AngioDynamics, Inc.
Cardiovascular · 342d
Cleared Mar 17, 1998
IMMUSTRIP HAMA IGG
K972873 · DAK
Immunomedics, Inc.
Immunology · 225d
Cleared Mar 17, 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · LYR
Shield Diagnostics, Ltd.
Microbiology · 218d
Cleared Mar 17, 1998
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129 · KPM
Denver Biomaterials, Inc.
Gastroenterology & Urology · 208d
Cleared Mar 17, 1998
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
K973364 · KNX
Maersk Medical A/S
Gastroenterology & Urology · 190d
Cleared Mar 17, 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · FRN
Abbott Laboratories
General Hospital · 85d
Cleared Mar 17, 1998
IMIX DIGITAL THORAX SYSTEM
K974863 · KPR
Advanced Instrument Development, Inc.
Radiology · 78d
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