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
95425–95448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508 · LYR
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared Jan 21, 1997
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
K962796 · IYN
Medasonics, Inc.
Radiology · 187d
Cleared Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · CGA
Bayer Corp.
Chemistry · 140d
Cleared Jan 21, 1997
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
K964574 · JHI
Athena Medical Corp.
Chemistry · 68d
Cleared Jan 21, 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 21, 1997
ELECSYS PROLACTIN ASSAY
K964748 · CFT
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jan 21, 1997
SAS ONE-STEP PREGNANCY
K964995 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Jan 17, 1997
ORTHODOC PREOPERATIVE PLANNER MODEL 500
K960685 · HWT
Integrated Surgical Systems, Inc.
Orthopedic · 332d
Cleared Jan 17, 1997
SIRIUS 10, 10L, 40, 40L
K961275 · EFB
Micro-Mega Societe Anonyme
Dental · 289d
Cleared Jan 17, 1997
MEDILOG VISION
K961636 · OLZ
Oxford Instruments, Plc.
Neurology · 263d
Cleared Jan 17, 1997
MEDILOG MPA-S
K961638 · OLV
Oxford Instruments Medical Systems
Neurology · 263d
Cleared Jan 17, 1997
MEDILOG MR95
K961642 · GWQ
Oxford Instruments, Plc.
Neurology · 263d
Cleared Jan 17, 1997
HSW GMBH ARTHROSCOPE
K962075 · HRX
Henke Sass Wolf of America, Inc.
Orthopedic · 234d
Cleared Jan 17, 1997
DIGITAL IMAGE ANALYSIS SYSTEM
K962153 · LLZ
University of Washington
Radiology · 227d
Cleared Jan 17, 1997
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 226d
Cleared Jan 17, 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 210d
Cleared Jan 17, 1997
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
K962648 · CBQ
Ohmeda Medical
Anesthesiology · 193d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · CGA
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Jan 17, 1997
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · JZO
Diagnostic Products Corp.
Immunology · 123d
Cleared Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
K963872 · HET
Gynecare Innovation Center
Obstetrics & Gynecology · 113d
Cleared Jan 17, 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304 · MNH
Osteonics Corp.
Orthopedic · 80d
Cleared Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · LNH
General Electric Co.
Radiology · 80d
Cleared Jan 17, 1997
IPU RX-2
K964327 · LLZ
Medirex, Inc.
Radiology · 79d
Cleared Jan 17, 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330 · DZE
BioHorizons Implant Systems, Inc.
Dental · 78d