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
121969–121992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1991
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
K905847 · LJT
Strato Medical Corp.
General Hospital · 99d
Cleared Apr 05, 1991
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
K905851 · LJT
Strato Medical Corp.
General Hospital · 99d
Cleared Apr 05, 1991
MAST CLA ALLERGY SYSTEM
K910292 · DHB
Mast Immunosystems
Immunology · 72d
Cleared Apr 05, 1991
PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K
K910315 · LJS
Sorex Medical
General Hospital · 71d
Cleared Apr 05, 1991
MICROLINE SCREEN FOR METHAMPHETAMINE
K910525 · DIT
Drug Screening Systems, Inc.
Toxicology · 57d
Cleared Apr 05, 1991
RHEUMAJET RF
K910539 · DHR
Biokit USA, Inc.
Immunology · 67d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Apr 05, 1991
OSTEONICS CDH HIP STEM
K910922 · JDI
Osteonics Corp.
Orthopedic · 31d
Cleared Apr 05, 1991
DERMATEK 4000
K911057 · INX
Anacom General Corp.
Physical Medicine · 28d
Cleared Apr 05, 1991
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · DBF
Serono-Baker Diagnostics, Inc.
Immunology · 18d
Cleared Apr 05, 1991
MICROSURGICAL INSTRUMENTS
K911300 · HRX
Danek Medical, Inc.
Orthopedic · 11d
Cleared Apr 04, 1991
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES
K910036 · GAA
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Apr 03, 1991
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · EKS
Dentauraum, Inc.
Dental · 335d
Cleared Apr 03, 1991
COOLING TEETHERS
K902974 · KKO
Realgrow Intl. Corp.
Dental · 271d
Cleared Apr 03, 1991
VENAPULSE MODELS VP-25 AND VP-50
K903894 · JOW
Aci Medical, Inc.
Cardiovascular · 223d
Cleared Apr 03, 1991
CYTOMEGALOVIRUS (CMV) ELISA
K904456 · LFZ
Virotech, Inc.
Microbiology · 184d
Cleared Apr 03, 1991
DIAL-AWAY PAIN
K904457 · GZJ
R.F.P., Inc.
Neurology · 184d
Cleared Apr 03, 1991
RESPIRONICS' DIGITAL MANOMETER
K904935 · CAP
Respironics, Inc.
Anesthesiology · 153d
Cleared Apr 03, 1991
RESORBABLE BONE PLUG
K905740 · ESD
Zimmer, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 03, 1991
STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED
K905844 · LJT
Strato Medical Corp.
General Hospital · 97d
Cleared Apr 03, 1991
ELECTONE ITE MODEL PREMIER
K910097 · ESD
Electone, Inc.
Ear, Nose, Throat · 84d
Cleared Apr 03, 1991
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER
K910185 · JJE
Beckman Instruments, Inc.
Chemistry · 78d
Cleared Apr 03, 1991
ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150
K910211 · CAC
Deknatel, Inc.
Anesthesiology · 78d
Cleared Apr 03, 1991
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
K910227 · KXO
Medex, Inc.
Obstetrics & Gynecology · 75d