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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
120865–120888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1991
VASCULAR BIOPSY FORCEPS
K910840 · DWZ
Vascular Products, Inc.
Cardiovascular · 138d
Cleared Jul 15, 1991
FC2000
K911454 · JAA
S & S Inficon, Inc.
Radiology · 103d
Cleared Jul 15, 1991
XYZ IMAGING TABLE WITH FOOT PUMP
K911561 · IYZ
Med-Tron Products, Inc.
Radiology · 97d
Cleared Jul 15, 1991
E-Z LIFT IMAGING TABLE WITH FOOT PUMP
K911564 · IYZ
Med-Tron Products, Inc.
Radiology · 97d
Cleared Jul 15, 1991
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · HSD
Depuy, Inc.
Orthopedic · 90d
Cleared Jul 15, 1991
ISE/K+
K912649 · CEM
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Jul 12, 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · FRN
Baxter Healthcare Corp
General Hospital · 197d
Cleared Jul 12, 1991
MEDFLATOR INFLATION SYSTEM
K910958 · MAV
Medex, Inc.
Cardiovascular · 128d
Cleared Jul 12, 1991
SURGICAL GLOVES
K911134 · KGO
Kenwell International , Ltd.
General Hospital · 120d
Cleared Jul 12, 1991
ANGIOPLASTY INFLATOR
K911295 · MAV
Vastek
Cardiovascular · 109d
Cleared Jul 12, 1991
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595 · JDG
Dow Corning Wright
Orthopedic · 94d
Cleared Jul 12, 1991
ROTATING HEMOSTATIC VALVE
K911678 · DYB
Devices For Vascular Intervention, Inc.
Cardiovascular · 88d
Cleared Jul 12, 1991
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911891 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 74d
Cleared Jul 11, 1991
CENTAURI YAG LASER SYST, GYNECOLOGY
K904632 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 275d
Cleared Jul 11, 1991
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
K910212 · JYO
Acoustic Imaging Technologies Corp.
Radiology · 177d
Cleared Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · DXO
Baxter Healthcare Corp
Cardiovascular · 160d
Cleared Jul 11, 1991
HEMOGLOBIN REAGENT
K910745 · GKR
Toa Medical Electronics USA, Inc.
Hematology · 140d
Cleared Jul 11, 1991
COMFOR-DENT DENTURE LINER
K910795 · EBI
Comfort Acrylics Co.
Dental · 135d
Cleared Jul 11, 1991
REDFIELD INFRARED COAGULATOR
K911648 · KNS
Redfield Corp.
Gastroenterology & Urology · 90d
Cleared Jul 11, 1991
FETAL SCALP SPIRAL ELECTRODE
K911657 · HGP
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT
K911736 · CAI
Medical Assemblies, Inc.
Anesthesiology · 85d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT
K911737 · CCK
Medical Assemblies, Inc.
Anesthesiology · 85d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES FILTER
K911738 · CAH
Medical Assemblies, Inc.
General Hospital · 85d