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
135121–135144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1988
NEOLENS SUNGLASSES
K882813 · HQY
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 29, 1988
NEOLENS PRESCRIPTION SPECTACLE LENS
K882814 · HQG
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 28, 1988
MODIFIED MODEL SSD-650 SYSTEM
K873452 · IYO
Ge Medical Systems Information...
Radiology · 336d
Cleared Jul 28, 1988
MODIFIED PERIPHERAL DILATATION CATHETERS
K875175 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 224d
Cleared Jul 28, 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332 · DQX
Medrad, Inc.
Cardiovascular · 184d
Cleared Jul 28, 1988
CORDIS PTA DILATATION CATHETERS
K880612 · LIT
Cordis Corp.
Cardiovascular · 163d
Cleared Jul 28, 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933 · CEP
Amersham Corp.
Chemistry · 143d
Cleared Jul 28, 1988
MODEL BPS08 BLOOD PRESSURE MODULE
K881155 · DXN
Fresenius USA, Inc.
Cardiovascular · 132d
Cleared Jul 28, 1988
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
K881213 · KNX
Geneva Laboratories, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 28, 1988
GENT-L-KARE CLEANSING ENEMA SET
K881218 · FCE
Geneva Laboratories, Inc.
Gastroenterology & Urology · 128d
Cleared Jul 28, 1988
BAGGISH, HYSTEROSCOPE
K881249 · HIH
Bryan Corp.
Obstetrics & Gynecology · 127d
Cleared Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
K881816 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 91d
Cleared Jul 28, 1988
CATHETER WITHDRAWAL UNIT
K881878 · KNY
Eris Medical Technology
Gastroenterology & Urology · 85d
Cleared Jul 28, 1988
HARBOR CENTRAL VENOUS CATHETER
K881884 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 85d
Cleared Jul 28, 1988
KIRSCHNER SUPER-FIXATION SYSTEM
K881896 · JEC
Kirschner Medical Corp.
Orthopedic · 84d
Cleared Jul 28, 1988
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · DSB
Biodynamics Corp.
Cardiovascular · 78d
Cleared Jul 28, 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · DXO
Draeger Medical, Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER
K882034 · DWF
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
HEART-CHILL SALINE SLUSH PAD
K882035 · DWJ
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
PROPAQ 104(TM)
K882085 · DSK
Protocol Systems, Inc.
Cardiovascular · 71d
Cleared Jul 28, 1988
QTEST(TM) PREGNANCY
K882086 · JHI
Quidel Corp.
Chemistry · 71d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 70d
Cleared Jul 28, 1988
TUNNELING STYLET
K882097 · DRB
Quinton, Inc.
Cardiovascular · 70d
Cleared Jul 28, 1988
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · DXN
Ivy Biomedical Systems, Inc.
Cardiovascular · 65d