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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144049–144072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1986
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K861707 · CBK
Siemens Elema AB
Anesthesiology · 45d
Cleared Jun 19, 1986
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · KDI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 42d
Cleared Jun 19, 1986
MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER
K861951 · DYB
Teleflex, Inc.
Cardiovascular · 30d
Cleared Jun 19, 1986
MODEL RS-3 RADIOGRAPHIC STAND
K861995 · IYB
Medicor USA , Ltd.
Radiology · 27d
Cleared Jun 19, 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014 · DBF
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 19, 1986
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K862022 · JFB
Lic-Orthion
Physical Medicine · 22d
Cleared Jun 19, 1986
SWAN-NECK PERITONEAL DIALYSIS CATHETERS
K862046 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 21d
Cleared Jun 19, 1986
SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
K862048 · DQX
Murex Corp.
Chemistry · 21d
Cleared Jun 19, 1986
ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE
K862063 · HQC
Entravision, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1986
ENTRAVISION EP-500 I/A ECCO PACK
K862064 · HQC
Entravision, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1986
LENS-EZE
K862094 · HJK
Insight International, Inc.
Ophthalmic · 17d
Cleared Jun 19, 1986
NO. 100352 GALVANIC OXYGEN SENSOR
K862113 · CCL
Vascular Technology Incorporated
Anesthesiology · 16d
Cleared Jun 19, 1986
STERILE LAPAROTOMY GAUZE SPONGE
K862126 · EFQ
Anago, Inc.
General & Plastic Surgery · 15d
Cleared Jun 19, 1986
HCI MECONIUM ASPIRATOR
K862132 · BSY
Hospital Concepts, Inc.
Anesthesiology · 15d
Cleared Jun 19, 1986
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · BXN
Puritan Bennett Corp.
Anesthesiology · 15d
Cleared Jun 19, 1986
QUALI-MED'S OPERATING ROOM DRAPES
K862172 · KKX
Quali-Med, Inc.
General Hospital · 10d
Cleared Jun 19, 1986
RMP COMPANT CRICOTHYROTOMY EQUIPMENT STORAGE TRAY
K862197
Rmp Co.
General & Plastic Surgery · 10d
Cleared Jun 18, 1986
SKYLARK MODEL 1001 TENS DEVICE
K853898 · GZJ
Peleg Intl. Co.
Neurology · 271d
Cleared Jun 18, 1986
ENDO-LASE CD40 FOR NEUROSURGERY
K853900 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 271d
Cleared Jun 18, 1986
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · FRC
Parke-Davis Co.
General Hospital · 177d
Cleared Jun 18, 1986
BIOFEEDBACK MICROLAB
K860271 · HCC
Hrm Software/Div. of Human Relations...
Neurology · 142d
Cleared Jun 18, 1986
VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE
K860826 · DWL
Bauerfeind GmbH & Co.
General Hospital · 106d
Cleared Jun 18, 1986
NUTRI-CATH - FEEDING TUBE
K861090 · KNT
Gesco Intl., Inc.
Gastroenterology & Urology · 86d
Cleared Jun 18, 1986
ANTHRON CATHETERS & SETS
K861117 · FOZ
Toray Industries (America), Inc.
General Hospital · 85d