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
152497–152520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1984
INFANT RADIANT WARMER
K840792 · FMT
Hatch Bio Medical
General Hospital · 92d
Cleared May 25, 1984
THROAT MOI-STIR
K840807 · LFD
Kingswood Laboratories, Inc.
Dental · 91d
Cleared May 25, 1984
ENDO-JECT
K840943 · BTR
Autovage
Anesthesiology · 81d
Cleared May 25, 1984
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
K841021 · JOX
Hemotec, Inc.
Hematology · 74d
Cleared May 25, 1984
SPORSTRIP
K841583 · FRC
Skyland Scientific Services, Inc.
General Hospital · 38d
Cleared May 25, 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609 · CHL
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 25, 1984
COMPONENTS FOR POTASSIUM, SODIUM CHLO
K841610 · JGT
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 25, 1984
CODE-A-WELL SERIES 200 PLATE
K841632 · LIB
Plastic Injectors, Inc.
Microbiology · 35d
Cleared May 25, 1984
SELECTIVE CULTURE MED. SELECTIVE STREP
K841839 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
SELECTIVE CULTURE MED. PHENYLETHYL ALCO
K841840 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
DIFFERENTIAL CULTURE MED. MANNITOL SALT
K841841 · JSI
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
DSL FERRITIN IRMA
K841925 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 15d
Cleared May 25, 1984
MARQUEST MICRO STIK 9000 SERIES
K842008 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 8d
Cleared May 23, 1984
BIOMER * PLEDGET SUTURE BUTTRESS
K832138 · KGS
Ethicon, Inc.
General & Plastic Surgery · 327d
Cleared May 23, 1984
ESOPHOGRAL MULTIPROBE
K832903 · DRX
Vital Signs, Inc.
Cardiovascular · 268d
Cleared May 23, 1984
CIRCULATOR MINIBOOT
K833627 · DRN
Circulator Boot Corp.
Cardiovascular · 222d
Cleared May 23, 1984
ANGIOSCANE SPECTRUM ANALYZER
K834501
Unigon Industries, Inc.
Neurology · 154d
Cleared May 23, 1984
ANGIOSCAN FLO MAD SPECTRUM ANALYZER
K834525 · JOP
Unigon Industries, Inc.
Cardiovascular · 154d
Cleared May 23, 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · DTD
Telectronics, Inc.
Cardiovascular · 139d
Cleared May 23, 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · DTD
Telectronics, Inc.
Cardiovascular · 139d
Cleared May 23, 1984
TEC-3500 DEFIBRILLATOR
K840258 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 121d
Cleared May 23, 1984
EMERGENCY INFUSION DEVICE
K840455 · DYB
Arrow Intl., Inc.
Cardiovascular · 111d
Cleared May 23, 1984
WALDMANN SUNTANNING EQUIP-MODELS'S
K840555
Eurotan Intl.
General & Plastic Surgery · 105d
Cleared May 23, 1984
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · KRB
Gould, Inc.
Cardiovascular · 89d