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
93529–93552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 129d
Cleared May 08, 1997
DUKAL NON ADHERENT DRESSING
K970455 · EFQ
Dukal Corp.
General & Plastic Surgery · 91d
Cleared May 08, 1997
DUKAL ABD COMBINE PAD
K970457 · EFQ
Dukal Corp.
General & Plastic Surgery · 91d
Cleared May 08, 1997
EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
K970469 · DQO
Guidant Cardiac and Vascular Surgery
Cardiovascular · 90d
Cleared May 08, 1997
DASH 1000 PATIENT MONITOR
K970545 · DSI
Marquette Medical Systems, Inc.
Cardiovascular · 85d
Cleared May 08, 1997
DERMAMEND FOAM ISLAND DRESSING
K970600 · KMF
Dermarx Corp.
General & Plastic Surgery · 79d
Cleared May 08, 1997
UNITRON MODEL SOUND F/X CIC
K970692 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared May 08, 1997
VAPOR-TECH SLED ELECTRODE
K970717 · FAS
Northgate Technologies, Inc.
Gastroenterology & Urology · 70d
Cleared May 08, 1997
DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111
K970813 · LLZ
Denvu, Inc.
Radiology · 64d
Cleared May 08, 1997
RESOLUT REGENERATIVE MATERIAL
K970884 · LYC
W.L. Gore & Associates, Inc.
Dental · 59d
Cleared May 08, 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · DZE
Innova Corp.
Dental · 38d
Cleared May 08, 1997
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
K971286 · LCX
Excel Scientific, Inc.
Chemistry · 31d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · DKB
Beckman Instruments, Inc.
Toxicology · 31d
Cleared May 08, 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297 · HRS
KLS-Martin L.P.
Orthopedic · 30d
Cleared May 08, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
K971317 · KDD
National Healthcare Mfg. Corp.
General & Plastic Surgery · 29d
Cleared May 07, 1997
EUB-8000
K954220 · IYN
Hitachi Medical Corp. of America
Radiology · 604d
Cleared May 07, 1997
MAGNES 2500 WH BIOMAGNETOMETER
K962317 · OLY
Biomagnetic Technologies, Inc.
Neurology · 324d
Cleared May 07, 1997
WRIGHT PLASTER OF PARIS PELLETS
K963562 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 244d
Cleared May 07, 1997
VAIL 2000 ENCLOSED BED
K963622 · FNL
Vail Products, Inc.
General Hospital · 239d
Cleared May 07, 1997
VISTA BRITE TIP CATHETERS
K963962 · DQY
Cordis Corp.
Cardiovascular · 217d
Cleared May 07, 1997
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K964814 · DYB
Bipore, Inc.
Cardiovascular · 159d
Cleared May 07, 1997
SIMPLEX AIRBRATOR
K970249 · KOJ
Simplex Medical Systems, Inc.
Dental · 105d
Cleared May 07, 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 92d
Cleared May 07, 1997
LACTATE DEHYDROGENASE (LD)
K970684 · CFJ
Randox Laboratories, Ltd.
Chemistry · 72d