FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75409–75432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64...
K020410 · LON
Dade Behring, Inc.
Microbiology · 124d
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836 · JDK
Signus Medical, LLC
Orthopedic · 89d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 85d
Cleared Jun 11, 2002
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
K020869 · DKZ
Worldwide Medical Corp.
Toxicology · 85d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jun 11, 2002
COULTER CELLPREP
K021150 · GKH
Beckman Coulter, Inc.
Hematology · 62d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 11, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH...
K021561 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 29d
Cleared Jun 11, 2002
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K021667 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 21d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jun 10, 2002
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · NPL
Cook Biotech, Inc.
Dental · 437d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA,...
K014066 · LDJ
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK...
K014067 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297 · CHL
Nova Biomedical Corp.
Chemistry · 133d
Cleared Jun 10, 2002
OPTAX SYSTEM
K020800 · LQD
Optax Systems, Inc.
Neurology · 90d
Cleared Jun 10, 2002
CEFAR MEDICAL AB CEFAR PRIMO
K020803 · GZJ
Cefar Medical AB
Neurology · 90d
Cleared Jun 10, 2002
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
K020880 · MQX
Marknew Products
General Hospital · 84d
Cleared Jun 10, 2002
STARTOX DRUG OF ABUSE SCREENING TEST
K021006 · DKZ
Starplex Scientific, Inc.
Toxicology · 74d
Cleared Jun 10, 2002
TERUMO GAS FILTER
K021020 · CAH
Terumo Cardiovascular Systems Corp.
General Hospital · 73d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared Jun 10, 2002
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES...
K021388 · LYY
Seal Polymer Industries Bhd.
General Hospital · 39d
Cleared Jun 10, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH...
K021536 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 31d
Cleared Jun 10, 2002
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
K021598 · KGO
Eci Medical Technologies, Inc.
General Hospital · 26d