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
87721–87744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1998
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
K984324 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 14, 1998
MS-900S, MS-900SPM & MS-900SFM
K980845 · DXN
Mars Medical Products
Cardiovascular · 285d
Cleared Dec 14, 1998
RTM DVT PROSOFT CUFF MODEL NUMBER PS100
K981643 · JOW
R.T. Medical Services, Inc.
Cardiovascular · 220d
Cleared Dec 14, 1998
LATEX POWDER FREE EXAMINATION GLOVES
K981942 · LYY
Maika Rubber Products Sdn Bhd
General Hospital · 195d
Cleared Dec 14, 1998
BARTELS CINAKIT CMV ANTIGENEMIA
K982311 · GQH
Intracel Corp.
Microbiology · 166d
Cleared Dec 14, 1998
ESP7 VENOUS IMAGE
K982612 · KZA
Ironmaster, Inc.
General Hospital · 140d
Cleared Dec 14, 1998
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · FYA
Medline Industries, Inc.
General Hospital · 133d
Cleared Dec 14, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
K983199 · LFL
Fibra Sonics, Inc.
General & Plastic Surgery · 91d
Cleared Dec 14, 1998
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
K983309 · LTT
Accumed Intl., Inc.
Microbiology · 84d
Cleared Dec 14, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY...
K983340 · DBF
Beckman Coulter, Inc.
Immunology · 82d
Cleared Dec 14, 1998
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN...
K983489 · KGO
Ansell Perry
General Hospital · 70d
Cleared Dec 14, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME...
K983803 · LFZ
Zeus Scientific, Inc.
Microbiology · 47d
Cleared Dec 14, 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · DDR
Dade Behring, Inc.
Immunology · 28d
Cleared Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · MMI
Dade Behring, Inc.
Chemistry · 28d
Cleared Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Dec 14, 1998
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
K984225 · JJY
Bio-Rad
Chemistry · 19d
Cleared Dec 14, 1998
ELECSYS CALCHECK TROPONIN T
K984372 · JJY
Boehringer Mannheim Corp.
Chemistry · 7d
Cleared Dec 11, 1998
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K980626 · JDI
Howmedica Corp.
Orthopedic · 296d
Cleared Dec 11, 1998
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
K980632 · JWH
Howmedica Corp.
Orthopedic · 295d
Cleared Dec 11, 1998
ULTRACON ULTRAFILTRATOR
K981253 · FJI
Interpore Intl.
Gastroenterology & Urology · 249d
Cleared Dec 11, 1998
SD-956 ULTRASOUND THERAPY
K981449 · IMI
Skylark Device Co., Ltd.
Physical Medicine · 233d
Cleared Dec 11, 1998
STRATA, MODEL V.O.95
K981678 · MUJ
Rosses Medical Systems
Radiology · 213d
Cleared Dec 11, 1998
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500...
K982078 · LFX
Diagnostic Products Corp.
Microbiology · 179d
Cleared Dec 11, 1998
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR...
K982323 · ITX
Olympus America, Inc.
Radiology · 162d