FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134185–134208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1988
RUBBER BAND, STERILE
K882695 · ECI
Bioseal
Dental · 108d
Cleared Oct 13, 1988
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · KFM
3M Health Care, Sarns
Cardiovascular · 100d
Cleared Oct 13, 1988
CASF CANCELLOUS BONE SCREW, BT650
K882934 · HWC
Terray Manufacturing, Inc.
Orthopedic · 92d
Cleared Oct 13, 1988
ALLOPREP SYSTEM
K883065 · KIT
Osteotech, Inc.
Pathology · 85d
Cleared Oct 13, 1988
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · CAC
Deknatel, Inc.
Anesthesiology · 84d
Cleared Oct 13, 1988
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · IZL
Bennett X-Ray Corp.
Radiology · 83d
Cleared Oct 13, 1988
EP-STAT
K883152 · DQK
Coherent Systems, Inc.
Cardiovascular · 79d
Cleared Oct 13, 1988
PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT
K883221 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 76d
Cleared Oct 13, 1988
IRIS ND:YAG OPTHALMIC LASER
K883270 · LQJ
California Laboratories, Inc.
Ophthalmic · 71d
Cleared Oct 13, 1988
LARYNGOSCOPE
K883296 · CCW
Lothar Scharras
Anesthesiology · 70d
Cleared Oct 13, 1988
TECHNICON RA(TM) SYSTEMS - MAGNESIUM
K883326 · JGJ
Technicon Instruments Corp.
Chemistry · 66d
Cleared Oct 13, 1988
TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM
K883358 · DXH
Telescan Medical Systems
Cardiovascular · 65d
Cleared Oct 13, 1988
ARTHRO-TRAC(TM)
K883361 · HRX
Rudolph Beaver, Inc.
Orthopedic · 65d
Cleared Oct 13, 1988
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · CKD
Tech-Co, Inc.
Chemistry · 64d
Cleared Oct 13, 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · JJQ
Pharmacia, Inc.
Toxicology · 59d
Cleared Oct 13, 1988
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
K883439 · DTR
Medtronic Blood Systems, Inc.
Cardiovascular · 59d
Cleared Oct 13, 1988
STERI-TAG(TM) STERILE LABEL SETS
K883654 · LYV
Acacia Laboratories, Inc.
General & Plastic Surgery · 48d
Cleared Oct 13, 1988
HLE-1000 HIGH/LOW TREATMENT TABLE
K883659 · INQ
Rich-Mar Corp.
Physical Medicine · 48d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · LNH
Resonex, Inc.
Radiology · 42d
Cleared Oct 13, 1988
STERILE SURGICAL LATEX GLOVES
K883824 · KGO
Intl. Trading Ventures, Inc.
General Hospital · 34d
Cleared Oct 13, 1988
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
K883861 · JJY
Casco Standards
Chemistry · 30d
Cleared Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · LWJ
Osteonics Corp.
Orthopedic · 27d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Oct 13, 1988
VISION CREATINE KINASE
K883946 · CGS
Abbott Laboratories
Chemistry · 24d