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
80017–80040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2000
SPECIAL PROCEDURES HEAD COIL
K003386 · MOS
Midwest Rf, LLC
Radiology · 58d
Cleared Dec 27, 2000
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396 · MNR
Erich Jaeger, Inc.
Anesthesiology · 324d
Cleared Dec 27, 2000
PHORMAX EAGLE SCANNER SYSTEM
K001499 · MQB
Phormax Corp.
Radiology · 226d
Cleared Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 203d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · DXZ
Cook Biotech, Inc.
Cardiovascular · 197d
Cleared Dec 27, 2000
PHACOFRAGMENTATION SYSTEM MEGATRON
K002031 · HQC
Asclepion-Meditec AG
Ophthalmic · 177d
Cleared Dec 27, 2000
CARTOUCH
K002197 · DPS
Cardionics, Inc.
Cardiovascular · 160d
Cleared Dec 27, 2000
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
K002803 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 110d
Cleared Dec 27, 2000
PELVIC MUSCLE THERAPY
K002830 · HIR
Colonial Medical Supply
Gastroenterology & Urology · 107d
Cleared Dec 27, 2000
COMPUMEDICS SIESTA SYSTEM
K003175 · OLV
Compumedics Limited
Neurology · 78d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230 · JAK
Vital Images, Inc.
Radiology · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516 · LNH
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 27, 2000
XISCAN 6000 IMAGING SYSTEM
K003568 · OXO
Xitec, Inc.
Radiology · 37d
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643 · DQY
NuMED, Inc.
Cardiovascular · 30d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Dec 27, 2000
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · INI
Merits Health Products., Inc.
Physical Medicine · 16d
Cleared Dec 26, 2000
CRYOSURGICAL UNIT AND ACCESSORIES
K003050 · GEI
Cryogen, Inc.
General & Plastic Surgery · 85d
Cleared Dec 26, 2000
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · DCN
Diagnostic Products Corp.
Immunology · 57d
Cleared Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
K003677 · GKZ
Abx Diagnostics
Hematology · 27d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 22, 2000
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
K001955 · GEI
Aaron Medical Industries
General & Plastic Surgery · 178d
Cleared Dec 22, 2000
BIOTEQ I.V. (INTRAVENOUS) SET
K002449 · FPA
Bioteque Corp.
General Hospital · 135d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER,...
K002976 · DRF
St Jude Medical
Cardiovascular · 88d