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
138409–138432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1987
TANGENT SCREEN
K873919 · HOJ
Richmond Products, Inc.
Ophthalmic · 33d
Cleared Oct 28, 1987
PREMIER-TOTAL (TM) HIP
K873999 · JDI
Intermedics Orthopedics
Orthopedic · 27d
Cleared Oct 28, 1987
STAPHSLIDE
K874019 · JWX
Ncs Diagnostics, Inc.
Microbiology · 26d
Cleared Oct 28, 1987
MULTICHEM INORGANIC PHOSPHOROUS S0923
K874038 · CEO
Simmler, Inc.
Chemistry · 23d
Cleared Oct 28, 1987
IRON REAGENT
K874055 · JMO
Trace Scientific , Ltd.
Chemistry · 23d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079 · LDJ
Syva Co.
Toxicology · 22d
Cleared Oct 28, 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · LDJ
Syva Co.
Toxicology · 15d
Cleared Oct 28, 1987
BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)
K874172 · JSJ
Otisville Biopharm, Inc.
Microbiology · 15d
Cleared Oct 28, 1987
BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI
K874173 · JSJ
Otisville Biopharm, Inc.
Microbiology · 15d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · KXS
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS
K874200 · JXN
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY
K874201 · DIO
Syva Co.
Toxicology · 14d
Cleared Oct 27, 1987
TELSTAR PREWIRE SERIES
K871731 · LRS
Telstar Electronics, Inc.
General & Plastic Surgery · 175d
Cleared Oct 27, 1987
IN THE EAR & IN THE CANAL HEARING AID FACE PLATE
K871884 · LRB
Hearing Services, Inc.
Ear, Nose, Throat · 167d
Cleared Oct 27, 1987
USI BASIC. AG 1050. AG 1090
K873146 · ELC
Cranston Ind., Inc.
Dental · 77d
Cleared Oct 27, 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · LJT
C.R. Bard, Inc.
General Hospital · 74d
Cleared Oct 27, 1987
SINTERLOY
K873373 · EJS
Denpac Corp.
Dental · 64d
Cleared Oct 27, 1987
BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE
K873441 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 27, 1987
PULP PEN
K873644 · EAT
The Hygenic Corp.
Dental · 48d
Cleared Oct 27, 1987
COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM
K873671 · EKS
Coltene, Inc.
Dental · 46d
Cleared Oct 27, 1987
#24L SYSTEM
K873878 · EBF
Pentron Corp.
Dental · 35d
Cleared Oct 27, 1987
CM 5000R REMOTE AIRWAY PRESSURE
K873953 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 29d
Cleared Oct 26, 1987
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
K870028 · GXI
Radionics, Inc.
Neurology · 294d
Cleared Oct 26, 1987
SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
K872132 · IXY
Sopha Medical Systems, Inc.
Radiology · 145d