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
94321–94344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1997
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
K965055 · HET
Imagyn Medical, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 06, 1997
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
K965070 · QGH
Mecta Corp.
Neurology · 85d
Cleared Mar 06, 1997
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
K965078 · GWG
Neuro Navigational Corp.
Neurology · 77d
Cleared Mar 06, 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · DEW
Beckman Instruments, Inc.
Immunology · 76d
Cleared Mar 06, 1997
MEDICOM, TENS ELECTRODES
K965194 · GXY
Medicotest A/S
Neurology · 72d
Cleared Mar 06, 1997
CR PERFECT
K970087 · CGX
Chimera Research & Chemical, Inc.
Chemistry · 55d
Cleared Mar 06, 1997
LIPASE REAGENT SET (COLIPASE METHOD)
K970124 · CET
Teco Diagnostics
Chemistry · 51d
Cleared Mar 06, 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 44d
Cleared Mar 06, 1997
MEDLINE CIRCUMCISION TRAY
K970282 · HFX
Medline
Obstetrics & Gynecology · 41d
Cleared Mar 06, 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · MKJ
Contour Medical Technology, Inc.
Cardiovascular · 31d
Cleared Mar 06, 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424 · JHI
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 06, 1997
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
K970425 · LCX
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970452 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK PSA
K970458 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970459 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 05, 1997
BIOJECTOR 2000 MODEL 1B02000
K960373 · KZE
Bioject, Inc.
General Hospital · 404d
Cleared Mar 05, 1997
PS-41 6M PATIENT SIMULATOR
K963198 · DPS
Metron U.S., Inc.
Cardiovascular · 202d
Cleared Mar 05, 1997
EPILASER NORMAL MODE RUBY LASER
K963947 · GEX
Spectrum Medical Technologies, Inc.
General & Plastic Surgery · 154d
Cleared Mar 05, 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · DZE
Steri-Oss, Inc.
Dental · 134d
Cleared Mar 05, 1997
V-CATH
K964966 · FOZ
Hdc Corp.
General Hospital · 84d
Cleared Mar 05, 1997
S-SCORT (2500)
K964997 · BTA
Sscor
General & Plastic Surgery · 79d
Cleared Mar 05, 1997
LATEX EXAM GLOVES
K965155 · LYY
P.T. Irama Dinamika Latex
General Hospital · 72d
Cleared Mar 05, 1997
STERILE WATER PUMP
K970002 · EIA
Micro Motors, Inc.
Dental · 62d
Cleared Mar 05, 1997
AUROFLUID 22
K970044 · EJS
Metalor Dental USA Corp.
Dental · 58d