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
143041–143064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · JJX
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127 · JJW
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
BACTEC 13A MEDIUM (7H13)
K863191 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Sep 15, 1986
CARDS(TM) HCG-URINE
K863199 · JHI
Pacific Biotech, Inc.
Chemistry · 27d
Cleared Sep 15, 1986
NEIS NZY
K863216 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 26d
Cleared Sep 15, 1986
ALBUMIN PROCEDURE
K863263 · CIX
Data Medical Associates, Inc.
Toxicology · 21d
Cleared Sep 15, 1986
CARE + PLUS SUTURE REMOVAL TRAY
K863283
Welmed Systems, Inc.
General & Plastic Surgery · 21d
Cleared Sep 15, 1986
SUPERFIXATION(TM)
K863343 · KTT
Orthopaedic Device Corp.
Orthopedic · 17d
Cleared Sep 15, 1986
FACIAL MASSAGER, BATTERY POWERED
K863383 · ISA
General Physiotherapy, Inc.
Physical Medicine · 12d
Cleared Sep 12, 1986
CARDIAN II CR45A
K861621 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 136d
Cleared Sep 12, 1986
E-Z CLEAN
K862221 · GEI
American Medical Products, Inc.
General & Plastic Surgery · 93d
Cleared Sep 12, 1986
EZ LOAD MODEL 30, ALL LEVEL COT
K862441 · FPO
Ferno-Washington, Inc.
General Hospital · 78d
Cleared Sep 12, 1986
WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
K862471 · LRA
Institute of Logopedics
Ear, Nose, Throat · 74d
Cleared Sep 12, 1986
QUARTZ RODS TITANIUM RODS
K862472 · GEX
Quali-Med, Inc.
General & Plastic Surgery · 74d
Cleared Sep 12, 1986
MODEL 1010 AMBULATORY PH MONITORING SYSTEM
K862536 · FFT
Oxford Medilog, Inc.
Gastroenterology & Urology · 72d
Cleared Sep 12, 1986
FUNS-10, FUNS-11
K862551 · FGB
Reichert-Jung, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 12, 1986
OHMEDA 5410 VOLUME MONITOR
K862687 · BZK
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 12, 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · BZK
Ohmeda Medical
Anesthesiology · 59d
Cleared Sep 12, 1986
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · DXS
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1986
LASER ASSISTED SURGICAL LAPAROSCOPY KITS
K863241
Lifestream Int'L, Inc.
General & Plastic Surgery · 21d
Cleared Sep 12, 1986
CORDIPAK ANGIOGRAPHY TRAY
K863336
Angi-Pak Corp.
General & Plastic Surgery · 15d
Cleared Sep 12, 1986
NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE
K863360 · GEI
Richards Medical Co., Inc.
General & Plastic Surgery · 10d
Cleared Sep 12, 1986
CONCEPT INTRAVISION ARTHROSCOPE SYSTEM
K863396 · HRX
Concept, Inc.
Orthopedic · 9d
Cleared Sep 11, 1986
PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
K862107 · ODC
Penn Medical Devices, Inc.
Gastroenterology & Urology · 100d