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
154753–154776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1983
PULSAIR MODEL SP-1
K832177 · IRQ
Thermowave Medical Device Corp.
Physical Medicine · 156d
Cleared Dec 08, 1983
P-S MEDICAL BERLIN VISADUCT KIT
K832677 · KOA
Pudenz-Schulte Medical Research Corp.
Gastroenterology & Urology · 121d
Cleared Dec 08, 1983
DIAGNON B12 57CO RIA KIT
K832717 · CDD
Diagnon Corp.
Chemistry · 118d
Cleared Dec 08, 1983
COMFORT CUSHION DISPOS. ANALGESIS
K832752 · CBN
Mission Dental, Inc.
Anesthesiology · 115d
Cleared Dec 08, 1983
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · JHI
Organon, Inc.
Chemistry · 112d
Cleared Dec 08, 1983
FLAME PHOTOMETER T281-T282-T283
K832886 · JJO
Texas Intl. Laboratories, Inc.
Chemistry · 104d
Cleared Dec 08, 1983
VISION TWO, ONE/10 ONE/20 &24
K832895 · LLZ
Comtal Corp.
Radiology · 104d
Cleared Dec 08, 1983
CLINICAL TYMPANOMETER
K833045 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 93d
Cleared Dec 08, 1983
IMPACT 400 #1447X2
K833067 · JJE
Gilford
Chemistry · 91d
Cleared Dec 08, 1983
THYROID UPTAKE SYSTEM
K833140 · IZD
Advanced Medical Research Corp.
Radiology · 85d
Cleared Dec 08, 1983
REXILLIUM III
K833143 · EJH
Jeneric Ind.
Dental · 84d
Cleared Dec 08, 1983
METAVOX MV-1000 HEARING AID
K833152 · ESD
Metavox, Inc.
Ear, Nose, Throat · 84d
Cleared Dec 08, 1983
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM
K833154 · JJF
Nova Biomedical Corp.
Chemistry · 84d
Cleared Dec 08, 1983
LANCER ANALYZER CUPS
K833157 · JJC
Sherwood Medical Co.
Chemistry · 83d
Cleared Dec 08, 1983
ABNORMAL URINE CONTROL
K833191 · JJY
Biosan Laboratories, Inc.
Chemistry · 80d
Cleared Dec 08, 1983
NORMAL URINE CONTROL
K833192 · JJY
Biosan Laboratories, Inc.
Chemistry · 80d
Cleared Dec 08, 1983
DIGITAL RADIOGRAPHY SYS DUAL GANTRIES
K833237 · JAA
American Science and Engineering, Inc.
Radiology · 99d
Cleared Dec 08, 1983
WAKO GLUCOSE C
K833257 · CGA
Wako Chemicals USA, Inc.
Chemistry · 79d
Cleared Dec 08, 1983
ARTERIAL MICRO COLLECTION KIT
K833312 · JKA
Current Technologies, Inc.
Chemistry · 77d
Cleared Dec 08, 1983
AMBERLITE CG50 RESIN, 100-200 MESH
K833320 · KEA
Biosan Laboratories, Inc.
Pathology · 73d
Cleared Dec 08, 1983
IN THE EAR HEARING AID OMNI 100
K833333 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 72d
Cleared Dec 08, 1983
VENTREZYME EIA CONTROLS-IMMUNOASSAY
K833423 · JJY
Ventrex Laboratories, Inc.
Immunology · 66d
Cleared Dec 08, 1983
BLOOD SAFETY MODULE BSM2
K833440 · KOC
Hospal Medical Corp.
Hematology · 64d
Cleared Dec 08, 1983
CAPIJECT SYS CAPILLARY BLOOD COLLECT
K833475 · JKA
Terumo Medical Corp.
Toxicology · 63d