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
94873–94896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1997
SAFETY INJECTION SYSTEM
K962999 · EJI
Integritech, Inc.
Dental · 173d
Cleared Jan 22, 1997
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT...
K963263 · GKZ
Coulter Corp.
Hematology · 155d
Cleared Jan 22, 1997
SERAQUEST HSV IGG
K963282 · LGC
Quest Intl., Inc.
Microbiology · 154d
Cleared Jan 22, 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · HRX
Stryker Endoscopy
Orthopedic · 153d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963319 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963321 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963322 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
COHERENT ULTRAPULSE CO2 SURGICAL LASERS
K963339 · GEX
Coherent Medical Group
General & Plastic Surgery · 149d
Cleared Jan 22, 1997
CO 2 SMO PLUS
K963380 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 148d
Cleared Jan 22, 1997
RESTRICTIVE LIMB HOLDER
K963468 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
TUXEDO VEST RESTRAINT
K963474 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
PONCHO VEST RESTRAINT
K963475 · KID
Deroyal Industries, Inc.
Physical Medicine · 141d
Cleared Jan 22, 1997
DISPOSABLE LIMB HOLDER
K963476 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
K963480 · KID
Deroyal Industries, Inc.
Physical Medicine · 141d
Cleared Jan 22, 1997
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
K963548 · EIA
Mrlb Intl., Inc.
Dental · 139d
Cleared Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Jan 22, 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 127d
Cleared Jan 22, 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · HWC
Northwest Precision Technologies
Orthopedic · 113d
Cleared Jan 22, 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · EJK
Sybron Dental Specialties, Inc.
Dental · 93d
Cleared Jan 22, 1997
BIAFINE WOUND DRESSING EMULSION
K964240 · MGQ
Medix Pharmaceuticals Americas, Inc.
General & Plastic Surgery · 90d
Cleared Jan 22, 1997
NOVABED PATIENT TRANSFER SYSTEM
K964246 · FNL
Nova Technology Corp.
General Hospital · 90d
Cleared Jan 22, 1997
HEARTPORT ENDOCORONARY SINUS CATHETR
K964248 · DWF
Heartport, Inc.
Cardiovascular · 90d
Cleared Jan 22, 1997
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
K964279 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 86d
Cleared Jan 22, 1997
AUTOPRIME
K964283 · FPB
Arbor Technologies, Inc.
General Hospital · 86d