Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
68641–68664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2004
OPEN BORE SYRINGE
K041344 · FMF
Isotis NV
General Hospital · 57d
Cleared Jul 16, 2004
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
K041354 · MST
Sweden Diagnostics (Germany) GmbH
Immunology · 57d
Cleared Jul 16, 2004
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K041564 · LHI
Bioject Medical Technologies, Inc.
General Hospital · 36d
Cleared Jul 16, 2004
FENZIAN TREATMENT SYSTEM
K041575 · GZJ
Eumedic Limited
Neurology · 32d
Cleared Jul 16, 2004
QUINTON Q-TE
K041607 · MHX
Quinton Cardiology, Inc.
Cardiovascular · 31d
Cleared Jul 16, 2004
NEURA WRAP NERVE PROTECTOR
K041620 · JXI
Integra Lifesciences Corp.
Neurology · 30d
Cleared Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Jul 16, 2004
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · HCG
Micro Therapeutics, Inc.
Neurology · 29d
Cleared Jul 16, 2004
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K041702 · KXK
Ibt SA
Radiology · 24d
Cleared Jul 16, 2004
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · JMO
Olympus America, Inc.
Chemistry · 14d
Cleared Jul 15, 2004
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · JOW
Tyco Healthcare
Cardiovascular · 126d
Cleared Jul 15, 2004
CLIP-ON SPACER 20%
K041084 · FMF
Serono, Inc.
General Hospital · 80d
Cleared Jul 15, 2004
POCONE INFRARED SPECTROPHOTOMETER
K041148 · MSQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 73d
Cleared Jul 15, 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
K041225 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 66d
Cleared Jul 15, 2004
RESMED HOSPITAL FULL FACE MASK
K041362 · BZD
Resmed, Ltd.
Anesthesiology · 56d
Cleared Jul 15, 2004
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 43d
Cleared Jul 15, 2004
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K041745 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 17d
Cleared Jul 15, 2004
OXYGEN MEDICELS, CITICELS
K041773 · CCL
City Technology Limited
Anesthesiology · 14d
Cleared Jul 15, 2004
NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T
K041789 · DXN
Meditec Co., Ltd.
Cardiovascular · 13d
Cleared Jul 14, 2004
EUSURE BLOOD GLUCOSE MONITORING SYSTEM
K040678 · NBW
Eumed Biotechnology Co., Ltd.
Chemistry · 121d
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756 · FTM
Implex Corp.
General & Plastic Surgery · 112d
Cleared Jul 14, 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE...
K040980 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 14, 2004
TSH-CTK-3 IRMA
K041014 · JLW
DiaSorin, Inc.
Chemistry · 85d
Cleared Jul 14, 2004
AESKULISA ENA 6 S
K041753 · LLL
Aesku Diagnostics
Immunology · 15d