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
86881–86904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1999
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
K984425 · JIX
Boehringer Mannheim Corp.
Chemistry · 40d
Cleared Jan 20, 1999
LC MICROHYBRID
K984484 · EBF
S & C Polymer GmbH
Dental · 35d
Cleared Jan 20, 1999
CYNOSURE ERASURE LASER
K984517 · GEX
Cynosure, Inc.
General & Plastic Surgery · 30d
Cleared Jan 19, 1999
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
K982515 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 183d
Cleared Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · KWQ
Danek Medical, Inc.
Orthopedic · 158d
Cleared Jan 19, 1999
MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
K983527 · GCJ
Dofi Technologies, Inc.
General & Plastic Surgery · 103d
Cleared Jan 19, 1999
OPTUM, INTRAORAL CAMERA SYSTEM
K983739 · EIA
Camsight, Inc.
Dental · 89d
Cleared Jan 19, 1999
EBI SPINELINK SYSTEM
K984027 · MNI
Electro-Biology, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028 · KWL
Biomet, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
K984170 · LGD
Zeus Scientific, Inc.
Microbiology · 60d
Cleared Jan 19, 1999
D-SIGN I (R&D PROJECT DW263 #24)
K984451 · EJS
Ivoclar North America, Inc.
Dental · 35d
Cleared Jan 19, 1999
WORLD CLASS WHEELED CHAIR, MODEL SS
K984457 · IOR
Suiter Medical LLC
Physical Medicine · 35d
Cleared Jan 19, 1999
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
K984612 · MNI
Synthes Spine
Orthopedic · 26d
Cleared Jan 15, 1999
LASETTE
K983673 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 87d
Cleared Jan 15, 1999
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
K983678 · JAI
Elekta Instruments, Inc.
Radiology · 87d
Cleared Jan 15, 1999
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
K983689 · DRX
Medicotest A/S
Cardiovascular · 87d
Cleared Jan 15, 1999
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
K984119 · CFM
Wako Chemicals USA, Inc.
Chemistry · 58d
Cleared Jan 14, 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058 · FYA
Encompass Group, LLC
General Hospital · 217d
Cleared Jan 14, 1999
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
K982228 · DXH
Tz Medical, Inc.
Cardiovascular · 203d
Cleared Jan 14, 1999
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
K982329 · ITX
Endosonics Corp.
Radiology · 196d
Cleared Jan 14, 1999
AIRZONE PEAK FLOWMETER
K982334 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 196d
Cleared Jan 14, 1999
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
K982518 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 178d
Cleared Jan 14, 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · MFD
Medworks Corp.
Obstetrics & Gynecology · 170d
Cleared Jan 14, 1999
INTROCAN SAFETY IV CATHETER
K982805 · FOZ
B.Braun Medical, Inc.
General Hospital · 157d