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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154081–154104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1984
VENTREX PREGNANCY TEST KIT ENZYME
K833960 · JHI
Vxr, Inc.
Chemistry · 79d
Cleared Feb 03, 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · JHI
Hybritech, Inc.
Chemistry · 74d
Cleared Feb 03, 1984
LUXENE VINYL-JECT 3600-80
K834046 · EBF
Howmedica Corp.
Dental · 72d
Cleared Feb 03, 1984
SCHEIN COTTON ROLLS, NON-STERILE
K834056 · EFN
Henry Schein, Inc.
Dental · 72d
Cleared Feb 03, 1984
MAGNESIUM B TEST
K834075 · JGJ
Wako Chemicals USA, Inc.
Chemistry · 70d
Cleared Feb 03, 1984
CONTACT-K APTT REAGENT
K834086 · GGN
Pacific Hemostasis
Microbiology · 67d
Cleared Feb 03, 1984
BLOOD GLUCOSE MONITOR
K834099 · JJQ
Healthdyne, Inc.
Hematology · 67d
Cleared Feb 03, 1984
ANTACHE ANTI-HEADACHE DEVICE
K834111 · HCC
Bio Sig Instruments, Inc.
Neurology · 66d
Cleared Feb 03, 1984
ALEXOLOK BRACKET
K834272 · EJF
Alexotek Co.
Dental · 57d
Cleared Feb 03, 1984
IMMUNO-CRP
K834390 · DCN
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
IMMUNO-RA
K834391 · DHR
Immunostics Co., Inc.
Microbiology · 51d
Cleared Feb 03, 1984
LIQUI-SERA TDM CALIBRATORS
K834398 · DKB
Biodiagnostic Intl
Toxicology · 51d
Cleared Feb 03, 1984
EMIT QST PHENYTOIN ASSAY
K834406 · DIP
Syva Co.
Toxicology · 51d
Cleared Feb 03, 1984
MUELLER-HINTON AGAR PLATE
K834421 · JTZ
Otisville Biotech, Inc.
Microbiology · 50d
Cleared Feb 03, 1984
TDX PROCAINAMIDE
K834464 · LAR
Abbott Laboratories
Toxicology · 45d
Cleared Feb 03, 1984
DNASE AGAR W/TOLUDINE BLUE PLATE
K840071 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
ESCULIN AGAR PLATE
K840073 · JSH
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
TRYPTICASE SOY BROTH TUBE
K840075 · JSG
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 03, 1984
THIOGLYCOLLATE MEDIUM TUBE
K840077 · JSG
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 01, 1984
EVERTAN SUNTAN BEDS
K834493 · FTC
Oregon Beauty Supply
General & Plastic Surgery · 64d
Cleared Jan 31, 1984
GEN. PURPOSE INSTRUMENT TRAYS &
K833058 · FSM
Inter-Med Corp.
General & Plastic Surgery · 145d
Cleared Jan 31, 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · JWH
Biomet, Inc.
Orthopedic · 78d
Cleared Jan 31, 1984
ANA TRANS TUBE & SWABS STERILE PACK
K834357 · JSL
Anaerobe Systems
Microbiology · 49d
Cleared Jan 31, 1984
SALON -BODY TANNING BED
K834492 · FTC
Grantan
General & Plastic Surgery · 62d