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
133633–133656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1988
CRYSTAR(TM) VINTAGE PORCELAIN
K884214 · ELL
Shofu Dental Corp.
Dental · 63d
Cleared Dec 08, 1988
BLOOD TUBING SET
K884243 · FJK
Mediflex Intl.
Gastroenterology & Urology · 58d
Cleared Dec 08, 1988
BAXTER DISPOSABLE CIRCUMCISION TRAY
K884290 · HFX
Baxter Healthcare Corp
Obstetrics & Gynecology · 57d
Cleared Dec 08, 1988
COOK HYSTEROCATH(TM)
K884291 · KNA
Cook, Inc.
Obstetrics & Gynecology · 57d
Cleared Dec 08, 1988
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 08, 1988
ULTRX(TM) 850 ARTIFICIAL KIDNEY
K884353 · KDI
Cd Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 08, 1988
MULTIFLOW(TM) 60 KIT
K884365 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 51d
Cleared Dec 08, 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · DTB
Ela Medical, Inc.
Cardiovascular · 55d
Cleared Dec 08, 1988
MARTIN-CHAMPY TITAN SET
K884523 · JEY
Buschmann Surgical Products
Dental · 42d
Cleared Dec 07, 1988
OTOMETER PORTABLE SCREENING AUDIOMETER
K883169 · EWO
Otometer, Inc.
Ear, Nose, Throat · 133d
Cleared Dec 07, 1988
APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR
K883904 · EIA
Apollo Dental Products, Inc.
Dental · 83d
Cleared Dec 07, 1988
FIBERLITE, FIBERLITE HS AND FIBERSEAL
K884038 · EBF
Jeneric/Pentron, Inc.
Dental · 72d
Cleared Dec 07, 1988
MIRAGE BOND
K884137 · KLE
Chameleon Dental Products, Inc.
Dental · 68d
Cleared Dec 07, 1988
TASSI MK2
K884835 · INX
Therapy Air Support Systems, Inc.
Physical Medicine · 19d
Cleared Dec 07, 1988
MODIFIED SAW BLADES TO THE SAGITAL SAW
K884839 · KIJ
Dyonics, Inc.
Orthopedic · 16d
Cleared Dec 06, 1988
GV3000 PHACOEMULSIFIER/FRAGMENTER
K883097 · HQC
D.O.R.C. Intl. B.V.
Ophthalmic · 137d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596 · CHI
Abbott Laboratories
Chemistry · 33d
Cleared Dec 06, 1988
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · DFH
Beckman Instruments, Inc.
Immunology · 55d
Cleared Dec 06, 1988
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Dec 06, 1988
UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000
K884836 · GEI
Meditron Devices, Inc.
General & Plastic Surgery · 18d
Cleared Dec 05, 1988
SYSTEM VI MONITOR
K874326 · DPS
Air-Shields, Inc.
Cardiovascular · 411d
Cleared Dec 05, 1988
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · CAF
Nidek, Inc.
Anesthesiology · 356d
Cleared Dec 05, 1988
POLYCORD II
K880303 · DSH
Technetics, Inc.
Cardiovascular · 315d
Cleared Dec 05, 1988
CHRONAMED CM101
K881206 · CCK
Chronamed Corp.
Anesthesiology · 259d