FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133297–133320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1989
CORTRONIC SCR1000
K884911 · DSF
Cortronic Corp.
Cardiovascular · 49d
Cleared Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
RS-CUP ACETABULAR PROSTHESIS
K885049 · KWA
Allo Pro Corp.
Orthopedic · 37d
Cleared Jan 13, 1989
MCCONNELL REAMER GUIDE
K885100 · HTO
Mcconnell Orthopedic
Orthopedic · 32d
Cleared Jan 13, 1989
#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
K885199 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 28d
Cleared Jan 13, 1989
600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE
K885200 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 28d
Cleared Jan 13, 1989
LINCOLN MILLS HIP HOLDER
K885215 · FWZ
Lincoln Mills, Inc.
General & Plastic Surgery · 25d
Cleared Jan 13, 1989
MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001
K885252 · DRQ
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Jan 13, 1989
MICROSCOPE SLIDES PRECOATED
K890042 · KEW
Stat Path
Pathology · 8d
Cleared Jan 12, 1989
SENSOCOR(TM) DIASYS
K881771 · DXN
Sensormedix, Inc.
Cardiovascular · 261d
Cleared Jan 12, 1989
CATH LAB MONITORING CATHETER
K884065 · DQO
C.R. Bard, Inc.
Cardiovascular · 108d
Cleared Jan 12, 1989
TORAY VASCULAR PROSTHESIS
K884083 · DSY
Toray Industries (America), Inc.
Cardiovascular · 107d
Cleared Jan 12, 1989
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
K884401 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408 · DTL
North American Instrument Corp.
Cardiovascular · 85d
Cleared Jan 12, 1989
DOPCORD PPG
K884451 · JOM
Huntleigh Technology, Inc.
Cardiovascular · 80d
Cleared Jan 12, 1989
HEAD HOLDING DEVICE/SLEEP APNEA
K884493 · IWY
X-Ray Systems
Radiology · 78d
Cleared Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647 · DQX
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 12, 1989
ROCKET FETAL BLOOD SAMPLING TRAY
K884685 · HGW
A & A Medical, Inc.
Obstetrics & Gynecology · 65d
Cleared Jan 12, 1989
OPTI-POINT
K884781 · HET
Plastic Injectors, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 12, 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 42d
Cleared Jan 12, 1989
THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM
K885088 · BYH
Thayer Medical Corp.
Anesthesiology · 31d
Cleared Jan 12, 1989
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · DSA
Medtronic Vascular
Cardiovascular · 31d