Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82033–82056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2000
PAIN CARE 3000
K002073 · MEB
Breg, Inc.
General Hospital · 71d
Cleared Sep 19, 2000
ULTRASORB SUTURE ANCHOR
K002413 · MAI
Li Medical Technologies, Inc.
Orthopedic · 43d
Cleared Sep 19, 2000
ASCENT KNEE SYSTEM
K002678 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 19, 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · JWH
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 19, 2000
BIS ENGINE
K002837 · OLW
Aspect Medical Systems, Inc.
Neurology · 7d
Cleared Sep 18, 2000
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
K000678 · ITI
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 202d
Cleared Sep 18, 2000
SERAGARD VASCULAR ACCESS PATCH
K001175 · FMI
Platinum Services, Inc.
General Hospital · 160d
Cleared Sep 18, 2000
ACTI-FLEX IV ADMINISTRATION SET
K001599 · FPA
R-Group Intl.
General Hospital · 117d
Cleared Sep 18, 2000
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
K001869 · IKT
Medicotest A/S
Neurology · 90d
Cleared Sep 18, 2000
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
K002255 · CCT
Wolfe Tory Medical, Inc.
Anesthesiology · 55d
Cleared Sep 18, 2000
MODIFICATION TO PANAVIA F
K002322 · EMA
Kuraray America, Inc.
Dental · 49d
Cleared Sep 18, 2000
PELVX GELLHORN VAGINAL PESSARY 603-608
K002329 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 48d
Cleared Sep 18, 2000
QUEST MPS BACK-UP SYSYEM
K002366 · DWF
Quest Medical, Inc.
Cardiovascular · 53d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF...
K002385 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 45d
Cleared Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD...
K002540 · JJX
Bionostics, Inc.
Chemistry · 33d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · FRN
Baxter Healthcare Corp
General Hospital · 21d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d
Cleared Sep 18, 2000
IPI HUMIDIFIER CHAMBER
K993282 · BTT
I.P.I. Medical Products
Anesthesiology · 354d
Cleared Sep 18, 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · LYY
Purna Bina Sdn Bhd
General Hospital · 264d
Cleared Sep 15, 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101,...
K000515 · MQV
Interpore Cross Intl.
Orthopedic · 212d
Cleared Sep 15, 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · MQG
Intl., Inc.
Obstetrics & Gynecology · 126d
Cleared Sep 15, 2000
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
K001842 · DQA
Somanetics Corp.
Anesthesiology · 88d
Cleared Sep 15, 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K002371 · KWQ
Spineology, Inc.
Orthopedic · 50d
Cleared Sep 15, 2000
DS DS I-SERIES
K002553 · KPS
Smv America
Radiology · 29d