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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145657–145680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1985
HI-TECH LAB MODEL CONCHA ALL IN EAR
K853967 · ESD
Hi-Tech Laboratories, Inc.
Ear, Nose, Throat · 92d
Cleared Dec 27, 1985
MODULAR POWER BASE
K854051 · ITI
Everest & Jennings, Inc.
Physical Medicine · 85d
Cleared Dec 27, 1985
PLACIDO DISC
K854054 · HLR
Cutler Medical Instruments
Ophthalmic · 85d
Cleared Dec 27, 1985
PHACO PACKS, 1A PACKS & PACK COMPONENTS
K854116 · HQC
Medical Corp. of America
Ophthalmic · 80d
Cleared Dec 27, 1985
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL
K854147 · IOL
Battle Creek Equipment Co.
Physical Medicine · 77d
Cleared Dec 27, 1985
MARATHON POWER DRIVE-WHEELCHAIR
K854153 · ITI
Everest & Jennings, Inc.
Physical Medicine · 77d
Cleared Dec 27, 1985
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
K854225 · HQC
Advanced Medical Technology, Inc.
Ophthalmic · 70d
Cleared Dec 27, 1985
GDC 1453 CASTING ALLOY
K854285 · EJH
Deringer-Ney, Inc.
Dental · 63d
Cleared Dec 27, 1985
HYBRID POINTS
K854347 · DZP
Shofu Dental Corp.
Dental · 59d
Cleared Dec 27, 1985
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K854375 · HQC
CooperVision, Inc.
Ophthalmic · 58d
Cleared Dec 27, 1985
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490 · GRP
American Micro Scan
Microbiology · 45d
Cleared Dec 27, 1985
GRESCO N.P. DENTAL ALLOY
K854495 · EJH
Gresco Products, Inc.
Dental · 45d
Cleared Dec 27, 1985
BARD PARKER THORACIC VENT
K854634 · KDQ
Bd Becton Dickinson Vacutainer...
General Hospital · 38d
Cleared Dec 27, 1985
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · GWM
Cordis Corp.
Neurology · 37d
Cleared Dec 27, 1985
AMERICAN STERILE SURGICAL ABSORBENT TOWEL
K854739
American Hospital Supply Corp.
General & Plastic Surgery · 32d
Cleared Dec 27, 1985
LINK CANCELLOUS SCREWS
K854826 · HWC
Link America, Inc.
Orthopedic · 24d
Cleared Dec 27, 1985
LINK CORTICAL SCREWS
K854827 · HWC
Link America, Inc.
Orthopedic · 24d
Cleared Dec 25, 1985
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186 · CKA
Clinical Data, Inc.
Chemistry · 71d
Cleared Dec 24, 1985
LPA-1 PRESSURE MONITOR
K854022
Life Products, Inc.
Cardiovascular · 85d
Cleared Dec 24, 1985
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
K854262 · FZX
Meadox Surgimed, Inc.
General & Plastic Surgery · 62d
Cleared Dec 24, 1985
VITALOGRAPH COMPACT
K854526 · BZG
Vitalograph , Ltd.
Anesthesiology · 41d
Cleared Dec 24, 1985
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · DYB
Medtronic Vascular
Cardiovascular · 40d
Cleared Dec 24, 1985
MCGHAN INTEGRAL VALVE TISSUE EXPANDER
K854794 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 22d
Cleared Dec 24, 1985
SCALPEL, ONE-PIECE, DISPOSABLE
K854857 · GDX
Medelec Intl. Corp.
General & Plastic Surgery · 19d