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
80497–80520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Planmed OY
Radiology · 58d
Cleared Mar 15, 2001
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351 · JEY
Inion , Ltd.
Dental · 37d
Cleared Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · KNF
Hdc Corp.
Obstetrics & Gynecology · 30d
Cleared Mar 15, 2001
LORENZ FIDUCAIL SCREW
K010427 · HAW
Walter Lorenz Surgical, Inc.
Neurology · 30d
Cleared Mar 15, 2001
MODIFICATION TO ACTICOAT FOAM DRESSING
K010447 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · GTZ
Binax, Inc.
Microbiology · 21d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared Mar 15, 2001
SPIFE IFE CALIBRATOR AND CONTROL KIT
K010617 · DEW
Helena Laboratories
Immunology · 14d
Cleared Mar 15, 2001
NEMIO
K010631 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 581d
Cleared Mar 14, 2001
'ALL 2000' % OXYGEN ANALYZER
K002382 · CCL
Analytical Industries, Inc.
Anesthesiology · 222d
Cleared Mar 14, 2001
O2/CO2 NASAL FILTERLINE
K010024 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 70d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Dade Behring, Inc.
Chemistry · 65d
Cleared Mar 14, 2001
Y2000 POCKET RESCUE
K010191 · CBP
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 51d
Cleared Mar 14, 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · JEY
Inion , Ltd.
Dental · 36d
Cleared Mar 14, 2001
INNOVO
K010359 · FMF
Novo Nordisk A/S
General Hospital · 36d
Cleared Mar 14, 2001
SMOOTH-FLO CIRCUIT
K010402 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 30d
Cleared Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · JEY
Bionx Implants, Inc.
Dental · 6d
Cleared Mar 13, 2001
MEMOGRAPH
K001353 · HBW
Biomedical Ent., Inc.
Neurology · 319d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · JDR
Biomedical Ent., Inc.
Orthopedic · 319d
Cleared Mar 13, 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · CAF
Medisana USA, Inc.
Anesthesiology · 239d
Cleared Mar 13, 2001
PRONEB ULTRA MODEL NUMBER 85B0100
K002862 · BTI
Pari Holding Co.
Anesthesiology · 181d
Cleared Mar 13, 2001
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
K003017 · GAM
Gramsmed, LLC
General & Plastic Surgery · 167d