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
87961–87984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1998
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · HGM
Air-Shields, Inc.
Obstetrics & Gynecology · 329d
Cleared Oct 07, 1998
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI...
K974854 · JHO
Morax
Chemistry · 282d
Cleared Oct 07, 1998
ZYMED TELEMETRY SYSTEM
K980186 · DSI
Agilent Technologies
Cardiovascular · 260d
Cleared Oct 07, 1998
ACCU-BITE HOME KIT DISCLUDER
K980953 · MQC
Jerome M. Simon
Dental · 208d
Cleared Oct 07, 1998
HYDRAGEL 6 CSF KIT
K981048 · CFF
Morax
Immunology · 201d
Cleared Oct 07, 1998
URISCREEN
K981084 · JXA
Diatech Diagnostics,Inc.
Microbiology · 196d
Cleared Oct 07, 1998
ODC B2 BIPOLAR CUP
K982389 · KWY
Ortho Development Corp.
Orthopedic · 90d
Cleared Oct 07, 1998
COBE VACUUM RELIEF CHECK VALVE
K982406 · MJJ
Cobe Cardiovascular, Inc.
Cardiovascular · 89d
Cleared Oct 07, 1998
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
K982417 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 86d
Cleared Oct 07, 1998
CODA MPX30 MOTION ANALYSIS SYSTEM
K982425 · LXJ
Pinsco Inc. Dba B & L Engineering
Physical Medicine · 86d
Cleared Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
K982603 · LLL
Inova Diagnostics, Inc.
Immunology · 72d
Cleared Oct 07, 1998
MEDIVISION HYSTEROSCOPE
K982659 · HIH
Medivision Scope Service Center, Inc.
Obstetrics & Gynecology · 69d
Cleared Oct 07, 1998
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
K982679 · DDR
Spectral Diagnostics, Inc.
Chemistry · 68d
Cleared Oct 06, 1998
SPO2 FINGER PROBES
K973970 · DQA
Medical Cables, Inc.
Anesthesiology · 354d
Cleared Oct 06, 1998
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 06, 1998
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
K981024 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 201d
Cleared Oct 06, 1998
DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K982196 · KPR
GE Medical Systems
Radiology · 106d
Cleared Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA,...
K982245 · MHI
Biosite Incorporated
Microbiology · 102d
Cleared Oct 06, 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 06, 1998
7250 ULTRASOUND IMAGING SYSTEM
K982444 · IYO
Biosound Esaote, Inc.
Radiology · 84d
Cleared Oct 06, 1998
ULTRAPRO MODEL 98
K982563 · LLZ
Ramsoft, Inc.
Radiology · 75d
Cleared Oct 06, 1998
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · EBC
Dentsply Intl.
Dental · 75d
Cleared Oct 06, 1998
PHILIPS TOMOSCAN CS
K982631 · JAK
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 06, 1998
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 67d