FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
122569–122592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255 · JIW
Sigma Diagnostics, Inc.
Hematology · 71d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 03, 1991
GEM-PREMIER SYSTEM
K910305 · JGS
Mallinckrodt Sensor Systems, Inc.
Chemistry · 69d
Cleared Apr 03, 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · DLZ
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Apr 03, 1991
MICROZYME TSH ENZYME IMMUNOASSAY KIT
K910411 · JLW
Immunotech Corp.
Chemistry · 64d
Cleared Apr 03, 1991
TEETHMATE-F
K910424 · EMA
Kuraray Co.
Dental · 63d
Cleared Apr 03, 1991
GLUCOSE V
K910573 · CGA
Caro Med, Inc.
Chemistry · 51d
Cleared Apr 03, 1991
MCLAUGHLIN LAPAROSCOPIC GRASPER
K910578 · HIS
Marlo Surgical Technology
Obstetrics & Gynecology · 51d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 48d