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
158281–158304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1982
ECHO-PULSE KM555
K821736 · GXW
Rabar, Inc.
Neurology · 178d
Cleared Dec 09, 1982
EBV IGM TEST
K822734 · JRY
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Dec 09, 1982
DSL 1600
K822898 · CIA
Diagnostic Systems Laboratories, Inc.
Chemistry · 71d
Cleared Dec 09, 1982
INNOTRON FLUORIMETER SERIES ONE-10
K822942 · KHO
Innotron of Oregon, Inc.
Chemistry · 66d
Cleared Dec 09, 1982
KM-KAL L3
K823044 · JIX
Kmn Products, Inc.
Chemistry · 55d
Cleared Dec 09, 1982
DOSOMETRIC RELEASE STERILIZATION
K823058 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 52d
Cleared Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · KQG
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Dec 09, 1982
MYSTIK AUTOCLAVE TAPE
K823208 · JOJ
Mystik Corp.
General Hospital · 42d
Cleared Dec 09, 1982
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · CAH
Ohio Medical Products
General Hospital · 38d
Cleared Dec 09, 1982
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 37d
Cleared Dec 09, 1982
RESPIRATORY CIRCUIT ADAPTOR
K823287 · BZO
Thoratec Laboratories Corp.
Anesthesiology · 35d
Cleared Dec 09, 1982
CHOLESTEROL CHOD-PAP TEST
K823302 · CHH
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Dec 09, 1982
CENTRAL VENOUS CATHETER
K823351 · FOZ
Plasmedics, Inc.
General Hospital · 30d
Cleared Dec 09, 1982
OXYGEN MONITOR IL 408
K823374 · CCL
Instrumentation Laboratory CO
Anesthesiology · 27d
Cleared Dec 09, 1982
HEARING AID HB-33 RIONET
K823383 · ESD
Kindel & Anderson
Ear, Nose, Throat · 27d
Cleared Dec 09, 1982
HEARING AID HB-72 RIONET
K823384 · ESD
Kindel & Anderson
Ear, Nose, Throat · 27d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · DCK
Syva Co.
Immunology · 24d
Cleared Dec 09, 1982
PRISMA-C-REACTIVE PROTEIN CALIBRATORS
K823417 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 09, 1982
MICROSURGICAL GAUGE
K823436 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 09, 1982
MCGEE 26GA. SUCTION TUBE
K823437 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 09, 1982
STAINLESS STEEL PISTONS
K823483 · ETB
Humboldt Products
Ear, Nose, Throat · 16d
Cleared Dec 09, 1982
BIRT-A-PAD #730
K823492
Birtcher Corp.
General & Plastic Surgery · 16d
Cleared Dec 09, 1982
NASAL CANNULA
K823506 · CAT
Seven Harvest Intl. Import & Export
Anesthesiology · 15d