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
170521–170544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1978
GENERATORS, PULSE, MODELS 5988/5989
K781208 · DXY
Medtronic Vascular
Cardiovascular · 81d
Cleared Oct 03, 1978
GENERATOR, PULSE, MODEL 5997
K781252 · DXY
Medtronic Vascular
Cardiovascular · 74d
Cleared Oct 03, 1978
THERAPY UNIT & ELECTRODIAG.
K781314 · GXY
General Theraphysical, Inc.
Neurology · 64d
Cleared Oct 03, 1978
MUSCLE STIMULATION APPARATUS
K781315 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
ULTRASONIC THERAPY APPARATUS, 407
K781317 · IMI
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
DYNATRON 406 ELECTROTHERAPY APPARATUS
K781318 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
THERAPY APPAR. 422 INTERFERENTIAL
K781319 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
FOCISCAN ECHOVISOR SYSTEM
K781348
Metrix Teknika, Inc.
Obstetrics & Gynecology · 57d
Cleared Oct 03, 1978
MICRODILUTION STREP ID. PANEL
K781367 · JSS
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
MICRODILUTION GRAM-NEGATIVE ID. PANEL
K781368 · JSS
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
MICRODILUTION ANAEROBE ID. PANEL
K781369 · JSF
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
SPECIALTY SPONGES
K781420 · EFQ
Ipco Corp.
General & Plastic Surgery · 49d
Cleared Oct 03, 1978
STAT ULTRA VIOLET LIQUID
K781432 · JHS
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Oct 03, 1978
DELTA TEST ASSAY, HDL CHLORESTEROL
K781436
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Oct 03, 1978
BECKMAN ASTRA SYSTEM
K781442 · JJF
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Oct 03, 1978
AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT
K781466 · CDT
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared Oct 03, 1978
TRIGLYCERIDES TEST KIT
K781477 · CDT
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Oct 03, 1978
ACID PHOSPHATASE DIAG. KIT
K781489 · CJN
Sclavo, Inc.
Hematology · 36d
Cleared Oct 03, 1978
ENZAC INCUBATOR
K781501 · JRG
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Oct 03, 1978
RIA SYSTEM FOR HUMAN FE-RITIN
K781527 · JMG
Calbiochem-Behring Corp.
Immunology · 28d
Cleared Oct 03, 1978
SMA/GGT
K781533 · JPZ
Technicon Instruments Corp.
Chemistry · 27d
Cleared Oct 03, 1978
SINGLE VIAL LDH-L TRIS
K781538 · CFJ
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Oct 03, 1978
EPPENDORF PCP 6121
K781544 · JJQ
Marilyn L. Amick
Chemistry · 25d
Cleared Oct 03, 1978
LIFTING CHAIR & LIFTING LAVATORY SEAT
K781559 · INO
Motor Riser Chairs , Ltd.
Physical Medicine · 22d