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
82105–82128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · OLW
Physiometrix, Inc.
Neurology · 88d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · DSB
Cardiodynamics International Corp.
Cardiovascular · 87d
Cleared Jun 30, 2000
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED,...
K001095 · CCL
Teledyne Analytical Instruments
Anesthesiology · 87d
Cleared Jun 30, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · GWF
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103 · GWQ
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
GENYX FLEXIBLE INJECTION NEEEDLE
K001146 · FBK
Geny Medical, Inc.
Gastroenterology & Urology · 81d
Cleared Jun 30, 2000
PERFORMER 30 HPS
K001322 · GEX
Cornelia Damsky, Inc.
General & Plastic Surgery · 65d
Cleared Jun 30, 2000
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K001611 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 36d
Cleared Jun 30, 2000
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT...
K001664 · MHX
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 29d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · JAK
Vital Images, Inc.
Radiology · 29d
Cleared Jun 30, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 28d
Cleared Jun 30, 2000
AGILENT COMPONENT MONITORING SYSTEM
K001722 · MHX
Agilent Technologies Deutschland GmbH
Cardiovascular · 24d
Cleared Jun 30, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
QUART ARTERIAL FILTER, MODEL HBF 140
K001787 · DTM
Jostra Medizintechnik AG
Cardiovascular · 17d
Cleared Jun 30, 2000
STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001801 · HAW
Medtronic Surgical Navigation
Neurology · 16d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001834 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 14d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001862 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 11d
Cleared Jun 30, 2000
UNICORN MODEL SYS0630
K001888 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Jun 30, 2000
RECTOSIGHT RS 300-04
K994130 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 206d
Cleared Jun 29, 2000
URANUS, COMFORTOUCH LASER SYSTEM
K001031 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 91d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080 · KWP
Aesculap, Inc.
Orthopedic · 86d