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
80881–80904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
K002866 · JJS
Bio-Rad
Chemistry · 12d
Cleared Sep 22, 2000
FREEDOM, MODEL 4660
K001023 · SEJ
Johnson & Johnson Consumer Companies,...
General & Plastic Surgery · 176d
Cleared Sep 22, 2000
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD...
K001926 · DYB
Thoratec Laboratories Corp.
Cardiovascular · 88d
Cleared Sep 22, 2000
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · INO
Medline Industries, Inc.
Physical Medicine · 88d
Cleared Sep 22, 2000
SYNTHES MODULAR FOOT SYSTEM
K001941 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
BOLUSPRO ULTRA
K002005 · JAK
Marconi Medical Systems, Inc.
Radiology · 81d
Cleared Sep 22, 2000
MMN-1 COARSE MANIPULATOR
K002653 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · HWC
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 22, 2000
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
K002658 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 22, 2000
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K002659 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 28d
Cleared Sep 21, 2000
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
K000825 · DQO
Medi-Dyne, Inc.
Cardiovascular · 191d
Cleared Sep 21, 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176 · HNO
Oasis Medical, Inc.
Ophthalmic · 163d
Cleared Sep 21, 2000
ZYBIT
K002004 · DXH
Zymed Medical Instrumentation
Cardiovascular · 80d
Cleared Sep 21, 2000
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
K002029 · DXN
Zoll Medical Corp
Cardiovascular · 80d
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · DXN
Critikon Company, LLC
Cardiovascular · 58d
Cleared Sep 21, 2000
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041,...
K002599 · FRO
Acrymed, Inc.
General & Plastic Surgery · 31d
Cleared Sep 21, 2000
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 6d
Cleared Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · JXG
Sophysa SA
Neurology · 426d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 20, 2000
MICOR CONDUCTION CATHETER
K001717 · BSO
Micor, Inc.
Anesthesiology · 107d
Cleared Sep 20, 2000
POLESTAR N-10
K002242 · LNH
Odin Technologies , Ltd.
Radiology · 58d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
K994340 · HLI
Hai Laboratories, Inc.
Ophthalmic · 272d