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
90433–90456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1998
ELECSYS CA 125 II
K972162 · LTK
Boehringer Mannheim Corp.
Immunology · 282d
Cleared Mar 18, 1998
UFR FIBEROPTIC CABLE
K972225 · FST
Universal Fiberoptic Repair, Inc.
General & Plastic Surgery · 278d
Cleared Mar 18, 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · MNH
Spinal Concepts, Inc.
Orthopedic · 173d
Cleared Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · JDW
Orthofix Srl
Orthopedic · 131d
Cleared Mar 18, 1998
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
K974544 · ITX
Aloka Co., Ltd.
Radiology · 104d
Cleared Mar 18, 1998
BIOZ.COM SYSTEM
K974725 · DSB
Cardiodynamics International Corp.
Cardiovascular · 90d
Cleared Mar 18, 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K974726 · JXG
Elekta Implants, SA
Neurology · 90d
Cleared Mar 18, 1998
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000
K974732 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
K974740 · LPH
Depuy, Inc.
Orthopedic · 89d
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