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

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176,076 results
69121–69144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2004
PHOSPHOPLASTIN RL
K040296 · GJS
R2 Diagnostics, Inc.
Hematology · 105d
Cleared May 24, 2004
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · MEB
I-Flow Corp.
General Hospital · 103d
Cleared May 24, 2004
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
K040378 · IXA
Eastman Kodak Company
Radiology · 97d
Cleared May 24, 2004
THINSET 1.8 ML RESERVOIR, MODEL 326A
K041152 · FRN
Applied Diabetes Research, Inc.
General Hospital · 21d
Cleared May 24, 2004
GRIFFIN SPECT/CT IMAGING SYSTEM
K041218 · KPS
Adac Laboratories
Radiology · 14d
Cleared May 24, 2004
RTA MODEL D RETINAL THICKNESS ANALYZER
K041290 · HLI
Talia Technology , Ltd.
Ophthalmic · 11d
Cleared May 24, 2004
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
K041295 · NHA
Institut Straumann AG
Dental · 10d
Cleared May 21, 2004
MODEL 509M PULSE OXIMETER, MODEL 509M
K032755 · DQA
Respironics Novametrix, Inc.
Anesthesiology · 259d
Cleared May 21, 2004
ZOLL AED PLUS
K033474 · MKJ
Zoll Medical Corp
Cardiovascular · 200d
Cleared May 21, 2004
CELSIUS CONTROL SYSTEM
K033623 · NCX
Innercool Therapies, Inc.
Neurology · 185d
Cleared May 21, 2004
Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
K033627 · CGA
Biomedix, Inc.
Chemistry · 184d
Cleared May 21, 2004
VITALAB IRON REAGENT
K033983 · JIY
Clinical Data, Inc.
Chemistry · 150d
Cleared May 21, 2004
I-TEC PORTABLE DENTAL OPERATORY
K040153 · EBW
Indigenous Peoples Technology and...
Dental · 119d
Cleared May 21, 2004
MICROMAX SUTURE ANCHOR
K040475 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared May 21, 2004
ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
K040639 · GXZ
Isurgical
Neurology · 72d
Cleared May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · LZG
Medtronic Minimed
General Hospital · 67d
Cleared May 21, 2004
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
K040735 · FSY
Alm S.A.
General & Plastic Surgery · 60d
Cleared May 21, 2004
CRYMED CRYO-ABLATOR
K040809 · GEH
Crymed Technologies, Inc.
General & Plastic Surgery · 53d
Cleared May 21, 2004
INTEGRITY TEMPORARY CEMENT
K040895 · EMA
Dentsply Intl.
Dental · 45d
Cleared May 21, 2004
NOA III ENTERAL NUTRITION PUMP
K040957 · LZH
Caesarea Medical Electronics , Ltd.
General Hospital · 38d
Cleared May 21, 2004
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
K041046 · JWH
Biomet, Inc.
Orthopedic · 29d
Cleared May 21, 2004
DOCUMENT SALICYLATE CAL VER
K041073 · JJY
Microgenics Corp.
Chemistry · 25d
Cleared May 21, 2004
SYNTEGRA
K041182 · KPS
Adac Laboratories
Radiology · 15d
Cleared May 21, 2004
RINSPIRATION SYSTEM
K041291 · DQO
Kerberos Proximal Solutions, Inc.
Cardiovascular · 7d