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
133033–133056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1988
PREEMICARE MODEL D1-X1, SERIES 3000
K881476 · FMZ
Preemicare Corp.
General Hospital · 245d
Cleared Dec 08, 1988
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · EIA
Aseptico, Inc.
Dental · 191d
Cleared Dec 08, 1988
MODIFIED L.J.'S SEX HELPER
K882531 · LKY
L.J. Fant & Co.
Gastroenterology & Urology · 169d
Cleared Dec 08, 1988
ODOR-END EMERGENCY CLEAN UP POWDER
K882878 · EXB
Cdc Products Corp.
Gastroenterology & Urology · 150d
Cleared Dec 08, 1988
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · FBK
Endovations
Gastroenterology & Urology · 139d
Cleared Dec 08, 1988
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · HIS
Carter Products
Obstetrics & Gynecology · 115d
Cleared Dec 08, 1988
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · LFJ
Impra, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825 · BYE
Respironics, Inc.
Anesthesiology · 90d
Cleared Dec 08, 1988
TECHMEDICA I.B.O. BLADE
K883922 · DZJ
Techmedica, Inc.
Dental · 83d
Cleared Dec 08, 1988
LAKE N/G EXTENSION SET
K884128 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 69d
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