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
145849–145872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1986
HEMOR-ICE
K854569 · LKX
Technology 2000
Gastroenterology & Urology · 83d
Cleared Feb 05, 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · JWY
Austin Biological Laboratories
Microbiology · 105d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · GQI
Clinical Sciences, Inc.
Microbiology · 76d
Cleared Feb 05, 1986
SPIROMETER, MODEL TS-500 PART #SLZ7534
K855068 · BTY
Teledyne Avionics Div. of Teledyne
Anesthesiology · 49d
Cleared Feb 05, 1986
TOURIQUET KIT WITH SNARE
K855144 · GDJ
Dlp, Inc.
General & Plastic Surgery · 41d
Cleared Feb 05, 1986
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
K855205 · JSI
Hana Biologics, Inc.
Microbiology · 37d
Cleared Feb 05, 1986
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
K860056 · KCW
Berkowits School of Electrolysis, Inc.
General & Plastic Surgery · 30d
Cleared Feb 05, 1986
RX02 PLUS OXYGEN CONCENTRATOR
K860060 · CAW
The John Bunn Co.
Anesthesiology · 30d
Cleared Feb 05, 1986
ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
K860063 · LNK
Laser Media
Gastroenterology & Urology · 30d
Cleared Feb 05, 1986
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
K860152 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 21d
Cleared Feb 05, 1986
CAPD TRANSFER SET SPIKE 5C4363
K860230 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 14d
Cleared Feb 05, 1986
JMS AV FISTULA NEEDLE
K860241 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 12d
Cleared Feb 05, 1986
RPMI 1640 W/GLUTAMINE W/HEPES
K860282 · KIT
Newport Biosystems, Inc.
Pathology · 8d
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · KIR
Difco Laboratories, Inc.
Pathology · 8d
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293 · KIR
Difco Laboratories, Inc.
Pathology · 8d
Cleared Feb 05, 1986
PYR DISCS
K860302 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Feb 04, 1986
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
K853540 · GQX
Idt, A Division of Whittaker M.A....
Microbiology · 165d
Cleared Feb 04, 1986
HARMO SONIC
K853841 · ELC
U.S. Shizai Corp.
Dental · 141d
Cleared Feb 04, 1986
FASCILULATED NAIL
K854227 · HSB
The Deca Co.
Orthopedic · 109d
Cleared Feb 04, 1986
ASSERACHROM IX:AG
K854312 · GGP
American Bioproducts Co.
Hematology · 99d
Cleared Feb 04, 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · HHR
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 98d
Cleared Feb 04, 1986
ASSERACHROM FPA KIT
K854384 · DAN
American Bioproducts Co.
Hematology · 97d
Cleared Feb 04, 1986
BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
K854466 · OLY
Biomagnetic Technologies, Inc.
Neurology · 90d
Cleared Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488 · GQN
Ortho Diagnostic Systems, Inc.
Microbiology · 88d