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
137929–137952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1987
A-QC CLINICAL CHEMISTRY CONTROL
K873611 · JJY
Arden Medical Systems, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
ACA URINE BARBITURATES SCREEN METHOD
K873623 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 42d
Cleared Oct 20, 1987
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)
K873625 · JLM
Boots-Celltech Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 20, 1987
OSMOMETER MODEL 110
K873642 · JJM
Advanced Instruments, Inc.
Chemistry · 41d
Cleared Oct 20, 1987
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · GIO
Ventrex Laboratories, Inc.
Hematology · 41d
Cleared Oct 20, 1987
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
K873677 · BTI
Mountain Medical Equipment, Inc.
Anesthesiology · 36d
Cleared Oct 20, 1987
MULTICHEM CREATININE REAGENT S0917
K873725 · CGX
Simmler, Inc.
Chemistry · 35d
Cleared Oct 20, 1987
BERMUDA GRASS ALLERGEN DISC
K873770 · DHB
Incstar Corp.
Immunology · 34d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XP BEHIND-THE-EAR
K873798 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XL BEHIND-THE-EAR
K873799 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
INTERNATIONAL MODEL XM BEHIND-THE-EAR
K873800 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
K873814 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 20, 1987
ALBUMIN IN SERUM
K873862 · DCF
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
HAPTOGLOBIN
K873866 · DAD
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · LKL
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
REUSEABLE BREATHING TUBES
K873927 · BZO
Dryden Corp.
Anesthesiology · 25d
Cleared Oct 20, 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · CAZ
Arrow Intl., Inc.
Anesthesiology · 22d
Cleared Oct 20, 1987
RORERTAZZI NASOPHARYNGEAL AIRWAY
K873949 · BTQ
Penn Medical Devices, Inc.
Anesthesiology · 22d
Cleared Oct 20, 1987
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 20d
Cleared Oct 20, 1987
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054 · GGK
Fisher Scientific Co., LLC
Hematology · 15d
Cleared Oct 20, 1987
PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE
K874075 · GXY
Weaver & Co.
Neurology · 14d
Cleared Oct 19, 1987
URIC ACID PAP
K873363 · KNK
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Oct 19, 1987
VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
K873609 · INI
American Dynatec Corp.
Physical Medicine · 41d
Cleared Oct 19, 1987
GEMSTAR II SYSTEM
K873617 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d