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
88225–88248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1998
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120...
K980869 · DTB
Biotronik, Inc.
Cardiovascular · 188d
Cleared Sep 10, 1998
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
K981334 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 150d
Cleared Sep 10, 1998
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
K981344 · LJE
Uresil Corp.
Gastroenterology & Urology · 154d
Cleared Sep 10, 1998
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000...
K982120 · LLZ
Trex Medical Corp.
Radiology · 86d
Cleared Sep 10, 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · HET
Smith & Nephew, Inc.
Obstetrics & Gynecology · 84d
Cleared Sep 10, 1998
CAPIOX SX HARDSHELL RESEVOIR
K982223 · DTN
Terumo Medical Corp.
Cardiovascular · 78d
Cleared Sep 10, 1998
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 76d
Cleared Sep 10, 1998
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
K982397 · FWF
Angiolaz, Inc.
General & Plastic Surgery · 63d
Cleared Sep 10, 1998
BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
K982557 · KNS
Bard Interventional Products Div.
Gastroenterology & Urology · 50d
Cleared Sep 10, 1998
SURGEON'S GLOVE
K982589 · KGO
Shiva Medicare , Ltd.
General Hospital · 48d
Cleared Sep 10, 1998
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K982702 · GWM
Camino Neurocare, Inc.
Neurology · 38d
Cleared Sep 10, 1998
CYNOSURE CO3 ER:YAG LASER
K983034 · GEX
Cynosure, Inc.
General & Plastic Surgery · 10d
Cleared Sep 09, 1998
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE...
K980429 · DSI
Hewlett-Packard Co.
Cardiovascular · 217d
Cleared Sep 09, 1998
CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982517 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982519 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982520 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982523 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982524 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982526 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982528 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982669 · JTN
Oxoid , Ltd.
Microbiology · 40d
Cleared Sep 09, 1998
LIGHT SABER BONE BIOPSY NEEDLE
K982735 · KNW
Minrad, Inc.
Gastroenterology & Urology · 35d
Cleared Sep 09, 1998
MAXAIR NASAL DILATOR SYSTEM
K982929 · LWF
Hnl Technologies
Ear, Nose, Throat · 20d
Cleared Sep 08, 1998
CARDIOVIEW 3000 SOFTWARE
K974352 · LOS
Micromedical, Inc.
Cardiovascular · 293d