FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86929–86952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1999
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984036 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jan 13, 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · LYY
Mexpo Intl., Inc.
General Hospital · 62d
Cleared Jan 13, 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
K984066 · KGO
Omni Intl., Inc.
General Hospital · 58d
Cleared Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · JHX
Dade Behring, Inc.
Chemistry · 58d
Cleared Jan 13, 1999
MAINBOND A
K984140 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Jan 13, 1999
WAKO L-TYPE AMYLASE
K984184 · JFJ
Wako Chemicals USA, Inc.
Chemistry · 51d
Cleared Jan 13, 1999
ORAL-EZE ORAL FLUID COLLECTION SYSTEM
K984361 · PJD
Osborn Laboratories, Inc.
Chemistry · 37d
Cleared Jan 13, 1999
R-30 AESTHETIC RESTORATIVE
K984387 · EBF
Dentsply Intl.
Dental · 36d
Cleared Jan 13, 1999
MICROSTAT 2
K984485 · LRJ
Chemlink Laboratories, LLC
General Hospital · 27d
Cleared Jan 13, 1999
CARESIDE ALKALINE PHOSPHATASE
K990024 · CJE
Careside, Inc.
Chemistry · 8d
Cleared Jan 12, 1999
GOLDMAN MANUAL TONOMETER
K981432 · HKY
Golden Vision, Inc.
Ophthalmic · 267d
Cleared Jan 12, 1999
POSI-STOP/POSI-TRAC SYSTEM
K981997 · DZE
The Dental Medical Device Co., LLC
Dental · 218d
Cleared Jan 12, 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · FRN
Abbott Laboratories
General Hospital · 207d
Cleared Jan 12, 1999
CYBER-LASE 2000 CURING AND WHITENING LASER
K983654 · GEX
Ics of North America, Inc.
General & Plastic Surgery · 85d
Cleared Jan 12, 1999
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661 · EIA
Belmont Equipment Corp.
Dental · 85d
Cleared Jan 12, 1999
AMPLAID A311 SERIES
K983712 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 83d
Cleared Jan 12, 1999
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K984000 · LMD
Surgical Navigation Technologies, Inc.
Radiology · 63d
Cleared Jan 12, 1999
MEDRAD QUADRATURE CTL ARRAY COIL
K984159 · MOS
Medrad, Inc.
Radiology · 54d
Cleared Jan 12, 1999
SAGE 7
K984167 · LNI
GE Medical Systems
Radiology · 53d
Cleared Jan 12, 1999
OLYMPUS HX-20 SERIES LIGATING DEVICE
K984255 · MND
Olympus Corp of America
Gastroenterology & Urology · 43d
Cleared Jan 12, 1999
MODIFICATION OF: RHEO DOPPLEX II
K984307 · IYN
Huntleigh Healthcare, Inc.
Radiology · 41d
Cleared Jan 11, 1999
STERRAD 50 STERILIZER
K981625 · MLR
Advanced Sterilization Products
General Hospital · 249d
Cleared Jan 11, 1999
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · MHI
Genzyme Diagnostics
Microbiology · 105d
Cleared Jan 11, 1999
IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM...
K983563 · DZE
Imcor
Dental · 90d