FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94177–94200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1997
BK-A
K970204 · DTD
Biotronik, Inc.
Cardiovascular · 98d
Cleared Apr 29, 1997
ALIGNMENT INSTRUMENT
K970345 · HSZ
Richard Wolf Medical Instruments Corp.
Orthopedic · 90d
Cleared Apr 29, 1997
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K970418 · GZL
Pmt Corp.
Neurology · 84d
Cleared Apr 29, 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · GZJ
Apex Medical Corp.
Neurology · 84d
Cleared Apr 28, 1997
AS/3 NMT MODULE
K955026 · KOI
Datex Medical Instrumentation, Inc.
Anesthesiology · 543d
Cleared Apr 28, 1997
QUICKIE P300 SERIES
K963381 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
QUICKIE P100 SERIES
K963382 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
QUICKIE POWER WHEELCHAIRS P200 SERIES
K963385 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
MODEL 1920 WASTE GAS SCAVENGER
K963601 · CBN
G. Dundas Co.
Anesthesiology · 231d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916 · LDJ
Diagnostic Products Corp.
Toxicology · 210d
Cleared Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K964119 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400 · KTT
Alphatec Mfg., Inc.
Orthopedic · 175d
Cleared Apr 28, 1997
IMMERGE IMAGE CORRELATION
K970623 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 68d
Cleared Apr 28, 1997
CAP-35B III/CINE 275
K971128 · IXR
Jamieson Film Co.
Radiology · 32d
Cleared Apr 28, 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141 · CEC
Dade Chemistry Systems, Inc.
Chemistry · 31d
Cleared Apr 28, 1997
ADVENTURER
K971142 · IOR
T.E.S., Ltd.
Physical Medicine · 31d
Cleared Apr 25, 1997
VENTANA ANTI-S100 PRIMARY ANTIBODY
K941514 · DEH
Ventana Medical Systems, Inc.
Immunology · 1123d
Cleared Apr 25, 1997
SIMPLEX TENS
K953982 · GZJ
Armstrong Industries, Inc.
Neurology · 611d
Cleared Apr 25, 1997
DRAGER INCUBATOR 8000 IC
K954204 · FMZ
Drager, Inc.
General Hospital · 597d
Cleared Apr 25, 1997
SPACELABS MEDICAL ECG ANALYSIS SYSTEM
K962930 · DQK
Spacelabs Medical, Inc.
Cardiovascular · 270d
Cleared Apr 25, 1997
PARAMAX SALICYLATE REAGENT
K964715 · DKJ
Dade Intl., Inc.
Toxicology · 151d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · DDB
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · DEM
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
VSA 3000 VIBRATORYN SENSORY ANALYZER
K970180 · LLN
Eare Consulting Service
Neurology · 98d