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
147145–147168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · DTR
Shiley, Inc.
Cardiovascular · 91d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-50
K852807 · KFM
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Sep 30, 1985
TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
K852938 · KPE
Northern Customfab, Inc.
General Hospital · 82d
Cleared Sep 30, 1985
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · DLZ
Miles Laboratories, Inc.
Toxicology · 81d
Cleared Sep 30, 1985
H-H HUNTER ACTIVE TENDON IMPLANT
K853438 · HXA
Holter-Hausner Intl.
Orthopedic · 46d
Cleared Sep 30, 1985
BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER
K853453 · JJQ
Bio Automed Systems, Inc.
Chemistry · 45d
Cleared Sep 30, 1985
DEXTRA PRECISION POWER SYSTEM
K853489 · HWE
Chattanooga Group, Inc.
Orthopedic · 41d
Cleared Sep 30, 1985
AMOENA BREAST FORMS
K853822 · GBI
Coloplast Corp.
General & Plastic Surgery · 17d
Cleared Sep 30, 1985
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS
K853825 · KNK
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · CFR
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · CIX
Medical Analysis Systems, Inc.
Chemistry · 13d
Cleared Sep 30, 1985
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
K853887 · JIT
Biodiagnostic Intl
Chemistry · 11d
Cleared Sep 27, 1985
NOVATHERM
K851034 · KXZ
Medtech Products, Inc.
Radiology · 198d
Cleared Sep 27, 1985
DUNN VESSEL OCCLUDER-STERILE
K851739 · DXC
Richard J. Turner Assoc.
Cardiovascular · 151d
Cleared Sep 27, 1985
POLYGEL ULTRASOUND GEL
K851895 · IYO
Parker Laboratories, Inc.
Radiology · 150d
Cleared Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902 · HEM
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 150d
Cleared Sep 27, 1985
ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81
K852113 · FLE
Ars Enterprises, Inc.
General Hospital · 135d
Cleared Sep 27, 1985
ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000
K852114 · FLE
Ars Enterprises, Inc.
General Hospital · 135d
Cleared Sep 27, 1985
MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET
K852194 · LHD
Sharp Electronics Corp.
Obstetrics & Gynecology · 130d
Cleared Sep 27, 1985
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K852608 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 100d
Cleared Sep 27, 1985
ODONTO TOOTHBRUSH
K852691 · EFW
Action Hygiene Products, Inc.
Dental · 93d
Cleared Sep 27, 1985
WUNDERSHADE
K852868 · EBF
Harry J. Bosworth Co.
Dental · 81d
Cleared Sep 27, 1985
RHINOTEST MP
K853024 · BXQ
Intertronic, Inc.
Anesthesiology · 71d
Cleared Sep 27, 1985
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
K853320 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 59d