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
87217–87240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 11, 1998
SILVERSTREAK HYDROPHILIC GUIDEWIRE
K982543 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 143d
Cleared Dec 11, 1998
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
K982651 · HEL
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 134d
Cleared Dec 11, 1998
CDR - PAN MODEL 4700
K982661 · MQB
Schick Technologies, Inc.
Radiology · 134d
Cleared Dec 11, 1998
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
K983200 · GAA
Ximed/Prosure/Injectx
General & Plastic Surgery · 88d
Cleared Dec 11, 1998
POWER BLOCK
K983227 · EIE
Kreativ, Inc.
Dental · 87d
Cleared Dec 11, 1998
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · EIA
Sirona Dental Systems GmbH
Dental · 86d
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · IZH
Elscint, Inc.
Radiology · 81d
Cleared Dec 11, 1998
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K983320 · HIS
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 81d
Cleared Dec 11, 1998
DYNAREX TRACHEOSTOMY SPONGE
K983348 · EFQ
Dynarex Corp.
General & Plastic Surgery · 79d