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
93697–93720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1997
DEPUY LOW PROFILE BONE SCREW
K970929 · HWC
Depuy, Inc.
Orthopedic · 88d
Cleared Jun 09, 1997
OPPORTUNITY INC. GENERAL PURPOSE TRAY
K971062 · LRO
Opportunity, Inc.
General & Plastic Surgery · 77d
Cleared Jun 09, 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · HQC
Visioncare Devices, Inc.
Ophthalmic · 77d
Cleared Jun 06, 1997
STERRADD STERILIZATION SYSTEM
K954142 · FLE
Advanced Sterilization Products
General Hospital · 644d
Cleared Jun 06, 1997
BIO-PLEXUS DROP-IT NEEDLE HOLDER
K963748 · FMI
Bio-Plexus, Inc.
General Hospital · 262d
Cleared Jun 06, 1997
EXTRESAFE PHLEBOTOMY
K964042 · FMI
Specialized Health Products, Inc.
General Hospital · 241d
Cleared Jun 06, 1997
DOUBLE UP BREAST PUMP
K964396 · HGX
The Natural Choice Co., Inc.
Obstetrics & Gynecology · 214d
Cleared Jun 06, 1997
ANOKRYO
K964634 · FFP
Mk Conquest Intl., Inc.
Gastroenterology & Urology · 199d
Cleared Jun 06, 1997
GSI SA60 DPOAE SYSTEM
K970324 · ETW
Grason-Stadler, Inc.
Ear, Nose, Throat · 130d
Cleared Jun 06, 1997
PTCA GUIDEWIRE
K970376 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 123d
Cleared Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · LBS
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Jun 06, 1997
MODEL HNC NEUROVASCULAR ARRAY COIL
K970868 · MOS
Mri Devices Corp.
Radiology · 88d
Cleared Jun 06, 1997
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K970880 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 06, 1997
VISTA V-38 CIC
K970939 · ESD
Vista Labs
Ear, Nose, Throat · 85d
Cleared Jun 06, 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Jun 06, 1997
MAICO MA52
K971080 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 06, 1997
NEURO PULSE II,III
K971143 · ETN
Aaron Medical Industries
Ear, Nose, Throat · 70d
Cleared Jun 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240 · HEL
Alexander Mfg. Co.
Obstetrics & Gynecology · 65d
Cleared Jun 06, 1997
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · EWL
Atos Medical AB
Ear, Nose, Throat · 64d
Cleared Jun 06, 1997
SCIENTIFIC PLASTICS MODEL SP
K971299 · ESD
Scientific Plastics, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 06, 1997
INSTEAD, SOFTCUP
K971303 · HHE
Ultrafem, Inc.
Obstetrics & Gynecology · 59d
Cleared Jun 06, 1997
AQ OPIATES (MORPHINE) TEST
K971361 · DJG
Bionike Laboratories, Inc.
Toxicology · 56d
Cleared Jun 06, 1997
PRONE BREAST POSITIONING BOARD, MODEL #37-018
K971382 · IYE
Victoreen, Inc.
Radiology · 84d
Cleared Jun 06, 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d