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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103705–103728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1995
ENDOLAP INSUFFLATOR TUBING SET
K950219 · HIF
Endolap, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 23, 1995
DIGITAL 625HF
K950291 · IZO
Fischer Imaging Corp.
Radiology · 57d
Cleared Mar 23, 1995
HARMONY LINE PF
K950517 · EJT
Ivoclar North America, Inc.
Dental · 45d
Cleared Mar 23, 1995
PROSYS URIHESICE SYSTEM NL
K950690 · EXJ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 37d
Cleared Mar 23, 1995
PERMASEAL
K950859 · EBF
Ultradent Products, Inc.
Dental · 24d
Cleared Mar 23, 1995
PERMALUTE
K950860 · KLE
Ultradent Products, Inc.
Dental · 24d
Cleared Mar 23, 1995
NEOCAST C, V, S
K950951 · EJH
Neodontics, Inc.
Dental · 21d
Cleared Mar 23, 1995
DYRACT II RESTORATIVE
K950991 · EBF
Dentsply Intl.
Dental · 20d
Cleared Mar 22, 1995
DURACON STABILIZER FEMORAL COMPONENT AND INSERT
K932070 · JWH
Howmedica Corp.
Orthopedic · 693d
Cleared Mar 22, 1995
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
K940383 · LRJ
National Laboratories
General Hospital · 420d
Cleared Mar 22, 1995
MAHURKAR DUAL LUMEN CATHETER
K943349 · FOZ
Quinton, Inc.
General Hospital · 253d
Cleared Mar 22, 1995
SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
K943593 · ODF
Ovamed Corp.
Gastroenterology & Urology · 240d
Cleared Mar 22, 1995
GERTIE MARX NEEDLE
K943649 · BSP
Manan Medical Products, Inc.
Anesthesiology · 237d
Cleared Mar 22, 1995
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
K943658 · MMK
Sage Products, Inc.
General Hospital · 238d
Cleared Mar 22, 1995
ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
K943659 · MMK
Sage Products, Inc.
General Hospital · 238d
Cleared Mar 22, 1995
PHLEBOTOMY SHARPS DISPOSAL CONTAINERS
K943660 · MMK
Sage Products, Inc.
General Hospital · 238d
Cleared Mar 22, 1995
DIACIDE HD DISINFECTING SOLUTION
K944037 · LRJ
Gulfstream Medical
General Hospital · 216d
Cleared Mar 22, 1995
CONTROL III DISINFECTANT GERMICIDE
K944179 · LRJ
Maril Products, Inc.
General Hospital · 208d
Cleared Mar 22, 1995
1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
K945002 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 160d
Cleared Mar 22, 1995
2, 3 & 4 BANDADGE COMPRESS
K945004 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 160d
Cleared Mar 22, 1995
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · FYA
Baxter Healthcare Corp
General Hospital · 125d
Cleared Mar 22, 1995
KARL STORZ PLASTIC SURGERY ACCESSORIES
K945889 · GCM
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 111d
Cleared Mar 22, 1995
FMS ARTHROSCOPY CANNULA
K945973 · HRX
Future Medical Systems, Inc.
Orthopedic · 104d
Cleared Mar 22, 1995
IVALON OPHTHALMIC SPONGE
K946016 · HOZ
Ivalon
Ophthalmic · 103d