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
132673–132696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · DTB
Medtronic Vascular
Cardiovascular · 138d
Cleared Jan 17, 1989
DM100 (DISTAL MONITOR - 100)
K884135 · HCC
Bio.Logic, Inc.
Neurology · 109d
Cleared Jan 17, 1989
THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
K884158 · CCK
Ppg Industries, Inc.
Anesthesiology · 105d
Cleared Jan 17, 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
K884398 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Jan 17, 1989
TECNOL VARIABLE TENSION BANDAGE
K884440 · NAD
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 88d
Cleared Jan 17, 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 17, 1989
INTRODUCER SAFETY SYRINGE
K884490 · DQX
Arrow Intl., Inc.
Cardiovascular · 83d
Cleared Jan 17, 1989
SERVO VENTILATOR 900E
K884520 · CBK
Siemens-Elema Ventilation Systems
Anesthesiology · 82d
Cleared Jan 17, 1989
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
K884539 · DSI
Rmv Medical (Romavat, Inc.)
Cardiovascular · 81d
Cleared Jan 17, 1989
IMPULSE EPIDURAL ELECTRODE
K884663 · JXE
Impulse Systems, Inc.
Neurology · 71d
Cleared Jan 17, 1989
ESP 3-PHASE X-RAY GENERATORS
K884678 · IZO
Elscint, Inc.
Radiology · 70d
Cleared Jan 17, 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · LCS
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884708 · CGJ
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · BTO
Shiley, Inc.
Anesthesiology · 68d
Cleared Jan 17, 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · CEM
Ciba Corning Diagnostics Corp.
Chemistry · 64d
Cleared Jan 17, 1989
MODEL 3587A RESUME EPIDURAL LEAD
K884948 · GZB
Medtronic Vascular
Neurology · 53d
Cleared Jan 17, 1989
FR6000 FLOWMETER
K884973 · CAX
Key Instruments
Anesthesiology · 48d
Cleared Jan 17, 1989
MAGNESIUM TEST ITEM NUMBER: SR1019
K885022 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 17, 1989
MODEL 3487A PISCES EPIDURAL LEAD
K885033 · GZB
Medtronic Vascular
Neurology · 43d
Cleared Jan 17, 1989
HPD STERILE HUMIDIFYING CHAMBER
K885314 · BTT
Hpd Medical, Inc.
Anesthesiology · 19d
Cleared Jan 13, 1989
PROMO-RIST C.P.M.
K881314 · BXB
Professional Motion, Inc.
Physical Medicine · 291d
Cleared Jan 13, 1989
ELECTR-TRANSBLOTTER
K882344 · JJN
The W.E.P. Co.
Chemistry · 220d
Cleared Jan 13, 1989
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
K882633 · ESD
Ensoniq Corp.
Ear, Nose, Throat · 200d
Cleared Jan 13, 1989
STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT
K883373 · DZE
Denar Corp.
Dental · 157d