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
87385–87408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1999
ECHO-COAT ULTRASOUND NEEDLES
K983647 · MJG
Sts Biopolymers
General & Plastic Surgery · 96d
Cleared Jan 20, 1999
BIOSONIC ULTRASONIC SCALER SYSTEM
K983727 · ELC
Coltene/Whaledent, Inc.
Dental · 90d
Cleared Jan 20, 1999
MPS GRAVITY FLOW CONTROL SET
K983926 · FPA
Critical Device Corp.
General Hospital · 76d
Cleared Jan 20, 1999
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
K984122 · JQF
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Jan 20, 1999
LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
K984147 · LYY
Lovytex Sdn Bhd
General Hospital · 62d
Cleared Jan 20, 1999
ENLIGHT-2
K984217 · DYH
Sybron Dental Specialties, Inc.
Dental · 57d
Cleared Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331 · HWC
Orthopedic Designs, Inc.
Orthopedic · 48d
Cleared Jan 20, 1999
TIMX LOW BACK SYSTEM
K984348 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 20, 1999
VSP SYSTEM
K984350 · MNI
Depuy Motech Acromed
Orthopedic · 47d
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