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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120505–120528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 19, 1991
ENTREE CANNULA
K911813 · FBM
Core Dynamics, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 19, 1991
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826 · JHI
Disease Detection International, Inc.
Chemistry · 86d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · CHS
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jul 19, 1991
X-MARX
K911873 · JAC
Macbrud Corp. Medical Div.
Radiology · 81d
Cleared Jul 19, 1991
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
K911943 · ILO
Burke, Inc.
Physical Medicine · 79d
Cleared Jul 19, 1991
OLYMPIC WARMETTE
K911955 · LDQ
Olympic Medical Corp.
General & Plastic Surgery · 79d
Cleared Jul 19, 1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K911991 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024 · JJE
Wako Chemicals USA, Inc.
Chemistry · 77d
Cleared Jul 19, 1991
TARGET MICROALBUMINURIA TEST
K912246 · JIR
Texas Immunology, Inc.
Chemistry · 59d
Cleared Jul 19, 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared Jul 19, 1991
ELECTROLYTE CONTROL
K912513 · JJR
Verichem Laboratories, Inc.
Chemistry · 43d