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
120769–120792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1991
ADVANTAGE EP
K903734 · GWE
Clark Davis Medical Systems, Inc.
Neurology · 340d
Cleared Jul 22, 1991
BELSCOPE LARYNGOSCOPE
K904918 · CCW
Avulunga Pty. , Ltd.
Anesthesiology · 264d
Cleared Jul 22, 1991
HYPERLITE
K905168 · CBF
S.O.S. , Ltd.
Anesthesiology · 248d
Cleared Jul 22, 1991
UNIQUANT
K905435 · GWQ
Neuroconcepts, Inc.
Neurology · 230d
Cleared Jul 22, 1991
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · DCK
The Binding Site, Ltd.
Immunology · 220d
Cleared Jul 22, 1991
ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
K905752 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 210d
Cleared Jul 22, 1991
GENESYS AND THE ROI
K910002 · JAI
The Complete Systems Corp. Genesys
Radiology · 201d
Cleared Jul 22, 1991
FETALGARD 2000
K910169 · HGM
Analogic Corp.
Obstetrics & Gynecology · 188d
Cleared Jul 22, 1991
THERAPY CHAIR SYSTEM
K910648 · JAI
Radiation Technology, Inc.
Radiology · 158d
Cleared Jul 22, 1991
SURGICAL GLOVES
K910895 · KGO
Influx Pacific Sdn. Bhd.
General Hospital · 140d
Cleared Jul 22, 1991
INFUSABLE
K911216 · KZD
Biomedical Dynamics, Inc.
General Hospital · 125d
Cleared Jul 22, 1991
CMD/DLCO DIAGNOSTIC SPIROMETER
K911358 · BTY
Spirometrics, Inc.
Anesthesiology · 116d
Cleared Jul 22, 1991
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · JOW
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Jul 22, 1991
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
K911935 · DRR
Gould, Inc.
Cardiovascular · 82d
Cleared Jul 22, 1991
BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
K912007 · DXQ
Tecnadyne Scientific, Inc.
Cardiovascular · 77d
Cleared Jul 22, 1991
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
K912225 · IXW
3M Medical Products Group
Radiology · 63d
Cleared Jul 22, 1991
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
K912234 · BZG
Somnitec, Inc.
Anesthesiology · 66d
Cleared Jul 22, 1991
ANTIGENZ CHLAMYDIA
K912680 · LJC
Baxter Diagnostics, Inc.
Microbiology · 49d
Cleared Jul 22, 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729 · DKB
Syva Co.
Toxicology · 32d
Cleared Jul 22, 1991
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · CIG
Amersham Corp.
Chemistry · 32d
Cleared Jul 20, 1991
POSEY CUFFLATOR
K912723 · BSK
Posey Co.
Anesthesiology · 31d
Cleared Jul 19, 1991
CENTAURI/PEGASUS
K905802 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 203d
Cleared Jul 19, 1991
MONOPOLAR SPHINCTERTOME
K911787 · GEI
Everest Medical Corp.
General & Plastic Surgery · 88d
Cleared Jul 19, 1991
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · DYB
Cordis Corp.
Cardiovascular · 88d