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
81505–81528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2000
AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
K001502 · BZC
Erich Jaeger GmbH
Anesthesiology · 58d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 12, 2000
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K001524 · MQG
Thermoquest Corp.
Obstetrics & Gynecology · 57d
Cleared Jul 12, 2000
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K001587 · CAZ
Arrow Intl., Inc.
Anesthesiology · 50d
Cleared Jul 12, 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · DXF
NuMED, Inc.
Cardiovascular · 27d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891 · GKP
Bio/Data Corp.
Hematology · 21d
Cleared Jul 12, 2000
AMPLATZER SIZING BALLOON
K993248 · MJN
Aga Medical Corp.
Cardiovascular · 288d
Cleared Jul 11, 2000
PUMA DENTAL CHAIR AND UNIT
K000837 · EIA
Castellini S.P.A.
Dental · 120d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 11, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 11, 2000
INSIDE VIEW
K001217 · GCM
Monadnock Optics, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231 · HWC
New Deal, S.A.
Orthopedic · 85d
Cleared Jul 11, 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · LZU
Advanced Vision Science
Ophthalmic · 85d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jul 11, 2000
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256...
K001324 · OLT
Neuro Scan Labs
Neurology · 76d
Cleared Jul 11, 2000
SCULPTURE FLOW
K001623 · EBF
Jeneric/Pentron, Inc.
Dental · 46d
Cleared Jul 11, 2000
NEEDLELESS TRANSFER DEVICE
K001831 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 25d
Cleared Jul 11, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001861 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001863 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC...
K990144 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 539d
Cleared Jul 10, 2000
SENSATION -VACUUM ASSIST DEVICES
K000124 · LKY
Prosurg, Inc.
Gastroenterology & Urology · 174d