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
140905–140928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1987
P.T.H. METAL-BACKED ACETABULAR CUP
K870234 · JDL
Orthopaedic Device Corp.
Orthopedic · 58d
Cleared Mar 20, 1987
STERILE PROCEDURAL TRAYS
K870373 · KDD
Dimed, Intl.
General & Plastic Surgery · 50d
Cleared Mar 20, 1987
THREADED ACETABULAR COMPONENT
K870445 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 45d
Cleared Mar 20, 1987
IODOSORB POWDER
K870559 · KOZ
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 38d
Cleared Mar 20, 1987
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · DTB
Telectronics, Inc.
Cardiovascular · 46d
Cleared Mar 20, 1987
SATLITE/PB251 PULSE OXIMETER
K870621 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 36d
Cleared Mar 20, 1987
HEARTECH HFX, HEARING AID
K870723 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 20, 1987
EMIT NORTRIPTYLINE ASSAY
K870823 · LFG
Syva Co.
Toxicology · 17d
Cleared Mar 20, 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · DTB
Pacesetter Systems
Cardiovascular · 66d
Cleared Mar 20, 1987
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K870851 · IZO
Electromed Intl., Ltd.
Radiology · 17d
Cleared Mar 20, 1987
LOOK RETROBULBAR NEEDLES
K870902 · HMX
Look, Inc.
Ophthalmic · 15d
Cleared Mar 19, 1987
CANDIDATE(R) SUPER
K863499 · LRF
Mercia Diagnostics , Ltd.
Microbiology · 191d
Cleared Mar 19, 1987
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · DOE
Diagnostic Products Corp.
Toxicology · 162d
Cleared Mar 19, 1987
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
K864500 · LQY
Analytic Technology
Dental · 125d
Cleared Mar 19, 1987
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
K865055 · GKR
Diversa Corp.
Hematology · 85d
Cleared Mar 19, 1987
CONTRASYL IMPRESSION MATERIAL
K870011 · ELW
Contracap
Dental · 76d
Cleared Mar 19, 1987
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · CEC
American Dade
Chemistry · 65d
Cleared Mar 19, 1987
SOFT EAR STETHOSCOPE
K870600 · CBG
Kalajian Ent.
Anesthesiology · 37d
Cleared Mar 19, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Mar 19, 1987
CENTRIPREP CONCENTRATOR
K870690 · JJH
Amicon, Inc.
Chemistry · 28d
Cleared Mar 19, 1987
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740 · KLN
Diagnostic Products Corp.
Toxicology · 22d
Cleared Mar 19, 1987
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
K870809 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 16d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Mar 19, 1987
COAT-A-COUNT PCP KIT NUMBER TKPC1
K870875 · LCN
Diagnostic Products Corp.
Toxicology · 16d