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
107209–107232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1994
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243 · GBX
Deknatel, Inc.
General & Plastic Surgery · 649d
Cleared Jul 27, 1994
OPTICAL FRAMES AND SUNGLASSES
K926564 · HQY
Solstar Produktions GmbH
Ophthalmic · 573d
Cleared Jul 27, 1994
SCIMED(R) VENTURE(TM) INFUSION CATHETER
K931335 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 498d
Cleared Jul 27, 1994
CABOT MEDICAL BIPOLAR CUTTING FORCEPS
K932293 · KNS
Cabot Medical Corp.
Gastroenterology & Urology · 442d
Cleared Jul 27, 1994
MICRODRIVE
K934600 · HQE
Medical Instrument Development...
Ophthalmic · 306d
Cleared Jul 27, 1994
E-Z TEMP II
K934941 · KPD
Seven C'S, Inc.
General Hospital · 282d
Cleared Jul 27, 1994
COLIBRI
K940041 · BTR
Icor AB
Anesthesiology · 204d
Cleared Jul 27, 1994
DIAGNOSTIC II CATHETER
K940168 · DRF
Ep Technologies, Inc.
Cardiovascular · 201d
Cleared Jul 27, 1994
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
K941044 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 142d
Cleared Jul 27, 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · KKX
Depuy, Inc.
General Hospital · 134d
Cleared Jul 27, 1994
DISPOSABLE SURGICAL CABLE
K941839 · DSA
Conmed Andover Medical, Inc.
Cardiovascular · 105d
Cleared Jul 27, 1994
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
K942645 · BXH
B & F Medical Products, Inc.
Anesthesiology · 54d
Cleared Jul 27, 1994
MINIMUS II
K942777 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 57d
Cleared Jul 27, 1994
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
K942839 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 42d
Cleared Jul 27, 1994
GLADIATOR
K942932 · HQY
Gladiator Sports
Ophthalmic · 35d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · HAE
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 27, 1994
EASSUN HI-TECH OPTICS
K943202 · HQY
Ultimate Concepts, Inc.
Ophthalmic · 22d
Cleared Jul 27, 1994
MS-30 AUTOMATIC PERIMETER
K943234 · HPT
Marco Ophthalmic, Inc.
Ophthalmic · 21d
Cleared Jul 27, 1994
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 9d
Cleared Jul 27, 1994
VARIOUS TYPES OF MERCURIALS
K943461 · DXN
Rud Riester GmbH & CO KG
Cardiovascular · 9d
Cleared Jul 26, 1994
PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
K926338 · CAC
Deknatel, Inc.
Anesthesiology · 585d
Cleared Jul 26, 1994
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930738 · GAL
Deknatel, Inc.
General & Plastic Surgery · 529d
Cleared Jul 26, 1994
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · GAP
Deknatel, Inc.
General & Plastic Surgery · 529d
Cleared Jul 26, 1994
SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
K930740 · GAQ
Deknatel, Inc.
General & Plastic Surgery · 529d