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
83401–83424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Feb 24, 2000
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
K000034 · IYN
Optimal Imaging Systems, Inc.
Radiology · 49d
Cleared Feb 24, 2000
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
K000056 · JJX
Biocell Laboratories, Inc.
Chemistry · 48d
Cleared Feb 24, 2000
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · IKN
Motion Lab Systems, Inc.
Neurology · 31d
Cleared Feb 24, 2000
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316 · MSQ
Meretek
Microbiology · 23d
Cleared Feb 24, 2000
E.N.S.I. SYRINGE
K000572 · MEG
Tri-Ject Intl. Corp.
General Hospital · 2d
Cleared Feb 24, 2000
PH-100, MODEL 2104
K991346 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 311d
Cleared Feb 24, 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · MWI
Critikon Company, LLC
Cardiovascular · 202d
Cleared Feb 24, 2000
DEFINITE
K993514 · EBF
Degussa - Ney Dental, Inc.
Dental · 129d
Cleared Feb 24, 2000
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
K994014 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 90d
Cleared Feb 24, 2000
HORTMANN ECHOMASTER OAE ANALYZER
K994033 · EWO
Hortmann AG
Ear, Nose, Throat · 90d
Cleared Feb 24, 2000
7250 (MEGAS)
K994369 · IYN
Biosound Esaote, Inc.
Radiology · 59d
Cleared Feb 23, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000002 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · DTD
Medtronic Vascular
Cardiovascular · 30d
Cleared Feb 23, 2000
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
K000257 · JFH
Diagnostic Products Corp.
Immunology · 27d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364 · LFR
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365 · CGA
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Feb 23, 2000
EXEL INJECTION PLUG WITH CAP
K992290 · FPA
Exel Intl.
General Hospital · 231d
Cleared Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633 · GMQ
Centers For Disease Control and...
Microbiology · 119d
Cleared Feb 23, 2000
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · LBH
Pulpdent Corp.
Dental · 75d
Cleared Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY...
K994318 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY...
K994324 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 63d
Cleared Feb 23, 2000
IMMUNOCYT
K994356 · NBK
Diagnocure, Inc.
Pathology · 62d
Cleared Feb 23, 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 56d