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
95041–95064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1997
SIRIUS 180, 180L, 230, 230L
K961235 · EFB
Micro-Mega Societe Anonyme
Dental · 285d
Cleared Jan 08, 1997
NON-SHIELDED SURGICAL TROCAR AND SLEEVE
K963760 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 112d
Cleared Jan 08, 1997
LSI VIDEOSCOPIC DISPLAY SYSTEM
K963919 · GCJ
Lsi Solutions
General & Plastic Surgery · 100d
Cleared Jan 08, 1997
LASERSCOPE ERBIUM
K964076 · GEX
Laserscope
General & Plastic Surgery · 89d
Cleared Jan 08, 1997
LORI HEARING AID SIMULATOR
K964080 · KHL
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 89d
Cleared Jan 08, 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · DSI
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Jan 08, 1997
PERFECTA PLASMA SPRAY HIP STEM
K964218 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 78d
Cleared Jan 08, 1997
DURA-BOARD ARMBOARD
K964273 · GDC
Allen Medical Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jan 08, 1997
DEGANIA SILICONE INDENTI LOOPS
K964547 · DXC
Degania Silicone , Ltd.
Cardiovascular · 56d
Cleared Jan 08, 1997
CELL RECOVERY SYSTEM
K965037 · FDX
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 07, 1997
CPR BIO-BARRIER FACESHEILD
K960995 · CBP
O-Two Systems Intl., Inc.
Anesthesiology · 301d
Cleared Jan 07, 1997
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
K962585 · FNM
United Medical Equipment, Inc.
General Hospital · 190d
Cleared Jan 07, 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · DYB
Johnson & Johnson Medical, Inc.
Cardiovascular · 160d
Cleared Jan 07, 1997
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
K963620 · FNM
9th Wave, Inc.
General Hospital · 119d
Cleared Jan 07, 1997
VERSATEC 310 ELECTRODE
K963975 · DRX
Versatec, Inc.
Cardiovascular · 96d
Cleared Jan 07, 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · KPS
GE Medical Systems
Radiology · 92d
Cleared Jan 06, 1997
OXYLOG 2
K954731 · BZL
P.K. Morgan , Ltd.
Anesthesiology · 448d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K962305 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT...
K962768 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · FMI
Cutting Edge Technologies, Inc.
General Hospital · 119d
Cleared Jan 06, 1997
MODEL 90022 ROLLING STAND
K963672 · JOW
Augustine Medical, Inc.
Cardiovascular · 115d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER KIT
K964048 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER
K964050 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d