FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81385–81408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Dade Behring, Inc.
Hematology · 41d
Cleared Sep 26, 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL...
K002770 · LJT
Hdc Corp.
General Hospital · 20d
Cleared Sep 26, 2000
KETAC CEM U
K002793 · EMA
Espe Dental AG
Dental · 19d
Cleared Sep 25, 2000
LIPIDURE REWETTING DROPS
K000975 · MRC
Nof Corp.
Ophthalmic · 182d
Cleared Sep 25, 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874 · LJS
Utah Medical Products, Inc.
General Hospital · 97d
Cleared Sep 25, 2000
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL...
K001958 · MPB
Keystone Medical
Gastroenterology & Urology · 90d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 88d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · LBI
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865 · JJS
Bio-Rad
Chemistry · 12d
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