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
88729–88752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1998
LACTATE PRO SYSTEM
K980908 · KHP
Kdk Corp.
Chemistry · 185d
Cleared Sep 11, 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Sep 11, 1998
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103 · GWN
Synapsys, Inc.
Neurology · 88d
Cleared Sep 11, 1998
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K982216 · BZQ
Braebon Medical Corp.
Anesthesiology · 80d
Cleared Sep 11, 1998
KELLER PULSE OXIMETER, MODEL 850+
K982331 · DQA
Keller Medical Specialties Products,...
Anesthesiology · 71d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · MRR
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared Sep 11, 1998
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT...
K982744 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 36d
Cleared Sep 11, 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · KNT
Ballard Medical Products
Gastroenterology & Urology · 25d
Cleared Sep 10, 1998
CETYLCIDE-G
K974188 · MED
Kellerandheckman
General Hospital · 307d
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