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
96841–96864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1996
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
K950809 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 530d
Cleared Aug 05, 1996
CROSS-CHECKS EO GAS STERILIZATION MONITOR
K952244 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 451d
Cleared Aug 05, 1996
BRAINLAB CT/X-RAY LOCALIZER
K954861 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 287d
Cleared Aug 05, 1996
DIB INFUSOR
K955849 · MEB
Novacon Corp.
General Hospital · 222d
Cleared Aug 05, 1996
CRYPTO-CEL IF TEST
K955852 · MHJ
Techlab, Inc.
Microbiology · 223d
Cleared Aug 05, 1996
CRYPTO/GIARDIA-CEL IF TEST
K955897 · MHI
Techlab, Inc.
Microbiology · 223d
Cleared Aug 05, 1996
DIB INFUSOR-RA
K960318 · MEB
Novacon Corp.
General Hospital · 195d
Cleared Aug 05, 1996
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND...
K960574 · FHO
Sherwood Medical Co.
Gastroenterology & Urology · 175d
Cleared Aug 05, 1996
WAGNER REVISION STEM
K960588 · LZO
Intermedics Orthopedics
Orthopedic · 175d
Cleared Aug 05, 1996
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY
K961477 · CDT
Trace America, Inc.
Chemistry · 109d
Cleared Aug 05, 1996
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · KWT
Biomet, Inc.
Orthopedic · 104d
Cleared Aug 05, 1996
APR OVERSIZED HIP STEM
K961921 · LZO
Intermedics Orthopedics
Orthopedic · 80d
Cleared Aug 05, 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · HWC
Synthes (Usa)
Orthopedic · 74d
Cleared Aug 05, 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · HWE
Baxter Healthcare Corp
Orthopedic · 74d
Cleared Aug 05, 1996
OLYMPUS BASKET GRASPERS
K962367 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 47d
Cleared Aug 02, 1996
TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
K955760 · LGD
Bayer Corp.
Microbiology · 226d
Cleared Aug 02, 1996
ULTRAMAX/MODEL NUMBER A1
K960044 · LWI
Entlab OY
Radiology · 213d
Cleared Aug 02, 1996
CHROMAGAR CANDIDA
K960075 · JXC
Hardy Diagnostics
Microbiology · 204d
Cleared Aug 02, 1996
CBI 7520 READER
K961183 · JJQ
Columbia Bioscience, Inc.
Chemistry · 129d
Cleared Aug 02, 1996
PHILIPS 71 SERIES
K961770 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 86d
Cleared Aug 02, 1996
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
K961842 · LNH
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
K962125 · JJE
Bayer Corp.
Chemistry · 60d
Cleared Aug 02, 1996
GENESIS II CONSTRAINED SYSTEM
K962137 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 60d
Cleared Aug 02, 1996
HYDROGEL SKIN DRESSING
K962352 · NAE
North American Sterilization &...
General & Plastic Surgery · 45d