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
92377–92400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1997
Cordis Endeavor Infusion Catheter
K972110 · QEY
Cordis Corp.
Cardiovascular · 70d
Cleared Aug 14, 1997
DEXON VIOLET
K972566 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 36d
Cleared Aug 14, 1997
PIVOTING COMPENSATING FILTERS FOR THE HEAD
K972766 · KPR
Octostop, Inc.
Radiology · 21d
Cleared Aug 13, 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · DPS
Quinton, Inc.
Cardiovascular · 259d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · JTN
Oxoid , Ltd.
Microbiology · 103d
Cleared Aug 13, 1997
ALICE 4R SYSTEM
K971867 · OLV
Healthdyne Technologies, Inc.
Neurology · 85d
Cleared Aug 13, 1997
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005 · GGP
Reaads Medical Products, Inc.
Hematology · 75d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · MJZ
Abbott Diagnostics
Microbiology · 76d
Cleared Aug 13, 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482 · GGP
Reaads Medical Products, Inc.
Hematology · 42d
Cleared Aug 13, 1997
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN...
K972627 · GJT
Pacific Hemostasis
Hematology · 30d
Cleared Aug 13, 1997
VIGIL TDM CONTROLS
K972819 · DIF
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Aug 12, 1997
ECG REVIEW STATION
K942685 · DXJ
Mortara Instrument, Inc.
Cardiovascular · 1162d
Cleared Aug 12, 1997
IMZ TWIN PLUS SCREW
K963520 · DZE
Imz, GmbH
Dental · 343d
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511 · HRX
Smith & Nephew, Inc.
Orthopedic · 182d
Cleared Aug 12, 1997
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 172d
Cleared Aug 12, 1997
CHASE PHRENIC NERVE PAD
K971021 · DWF
Chase Medical, Inc.
Cardiovascular · 145d
Cleared Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · GKZ
Abbott Laboratories
Hematology · 137d
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · JJY
Boston Biomedica, Inc.
Microbiology · 98d
Cleared Aug 12, 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K971796 · EZL
Louisville Laboratories, Inc.
Orthopedic · 89d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · DQA
Alexander Mfg. Co.
Anesthesiology · 88d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · DQA
Alexander Mfg. Co.
Anesthesiology · 88d
Cleared Aug 12, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Aug 12, 1997
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING...
K971881 · FJL
Comeg Endoscopy
Gastroenterology & Urology · 84d
Cleared Aug 12, 1997
AMERIGEL OINTMENT SATURATED WOUND DRESSING
K971918 · MGQ
Amerx Health Care Corp.
General & Plastic Surgery · 81d