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
57625–57648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2008
IMIX INSIGHT X-RAY SYSTEMS
K073114 · KPR
Imix Adr Finland OY
Radiology · 73d
Cleared Jan 17, 2008
GILB-2, GLASS IONOMER PROTECTIVE COATING
K073395 · EMA
3M Espe Dental Products
Dental · 45d
Cleared Jan 17, 2008
GRYPHON BR AND HEALIX BR ANCHORS
K073412 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 44d
Cleared Jan 17, 2008
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
K073662 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 22d
Cleared Jan 17, 2008
REGISTRATION AND FUSION
K080013 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Jan 16, 2008
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
K063091 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 463d
Cleared Jan 16, 2008
CHAMELEON FIXATION SYSTEM
K071420 · MRW
Spinefrontier, Inc.
Orthopedic · 239d
Cleared Jan 16, 2008
ORTHO-WRAP BIORESORBABLE SHEET
K072190 · FTL
Mast Biosurgery
General & Plastic Surgery · 163d
Cleared Jan 16, 2008
CHEETAH RELIANT, CHEETAH ACTIVE
K072662 · DSB
Cheetah Medical, Inc.
Cardiovascular · 117d
Cleared Jan 16, 2008
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · MEG
Schreiner Medipharm
General Hospital · 64d
Cleared Jan 16, 2008
BIPORE BALLOON DILATION CATHETER
K073318 · LIT
Bipore, Inc.
Cardiovascular · 51d
Cleared Jan 16, 2008
PORTABLE ECSCOPE 12I
K080036 · DPS
Dyansys, Inc.
Cardiovascular · 9d
Cleared Jan 15, 2008
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
K072149 · LLL
Phadia US, Inc.
Immunology · 165d
Cleared Jan 15, 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090 · DTK
C.R. Bard, Inc.
Cardiovascular · 75d
Cleared Jan 15, 2008
PRESSURE INJECTABLE PICC
K073451 · LJS
Arrow International, Inc.
General Hospital · 36d
Cleared Jan 14, 2008
RICHTER MALE LATEX CONDOM
K070511 · HIS
Richter Rubber Technology Sbn Bhd
Obstetrics & Gynecology · 326d
Cleared Jan 14, 2008
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM,...
K071104 · FIP
Flier'S Quality Water Systems, Inc.
Gastroenterology & Urology · 270d
Cleared Jan 14, 2008
FINGERTIP PULSE OXIMETER, MODEL MD300I
K072825 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 104d
Cleared Jan 14, 2008
POINTCARE NOW SYSTEM
K072869 · GKZ
Pointcare Technologies, Inc.
Hematology · 97d
Cleared Jan 14, 2008
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
K072870 · NEY
Foundry Newco X, Inc.
General & Plastic Surgery · 97d
Cleared Jan 14, 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · HRX
Biomet Orthopedics, Inc.
Orthopedic · 97d
Cleared Jan 14, 2008
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
K072917 · DZE
Odontit S.A.
Dental · 94d
Cleared Jan 14, 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND...
K073431 · KHE
Tianjin New Bay Bioresearch Co., Ltd.
Hematology · 39d
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · LON
Becton, Dickinson & CO
Microbiology · 39d