FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86329–86352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1999
ROCS ULTRASEED
K984241 · IYE
Radiation Oncology Computer Systems
Radiology · 166d
Cleared May 12, 1999
CALCIUM SCORING
K990426 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 12, 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
K990441 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared May 12, 1999
1000 PRESSURE INFUSION SIGMACON 1000
K990447 · FRN
Valley West, Inc.
General Hospital · 89d
Cleared May 12, 1999
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
K990455 · LLZ
Philips Medical Systems, Inc.
Radiology · 89d
Cleared May 11, 1999
TRACER O-T-W MAPPING DEVICE
K972803 · DRF
Cardima, Inc.
Cardiovascular · 652d
Cleared May 11, 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · KHE
Ameritek, Inc.
Hematology · 201d
Cleared May 11, 1999
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K990011 · LPL
Continental Soft Lens, Inc.
Ophthalmic · 127d
Cleared May 11, 1999
CALCITONIN
K990073 · JKR
Kmi Diagnostics, Inc.
Chemistry · 120d
Cleared May 11, 1999
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
K990093 · DSI
Agilent Technologies
Cardiovascular · 120d
Cleared May 11, 1999
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
K990411 · HIH
Karl Storz Endoscopy
Obstetrics & Gynecology · 90d
Cleared May 11, 1999
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
K990442 · LLZ
Vital Images, Inc.
Radiology · 90d
Cleared May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550 · LNH
Ge Medical Systems, Inc.
Radiology · 78d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774 · DHX
Abbott Laboratories
Immunology · 63d
Cleared May 11, 1999
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
K990957 · JBL
Astoria-Pacific, Inc.
Hematology · 50d
Cleared May 11, 1999
COULTER Z2 ANALYZER
K991070 · GKL
Coulter Corp.
Hematology · 41d
Cleared May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · JZG
Olympus America, Inc.
Immunology · 36d
Cleared May 11, 1999
K-ASSAY CRP CALIBRATOR SET
K991210 · DCK
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 11, 1999
AIA-PACK FT3 ASSAY
K991252 · CDP
Tosoh Medics, Inc.
Chemistry · 28d
Cleared May 10, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983408 · JWY
Dade Microscan, Inc.
Microbiology · 224d
Cleared May 10, 1999
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
K984098 · LPL
Adventures IN Color Technology, Ltd.
Ophthalmic · 174d
Cleared May 10, 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K990480 · LPN
Alcon Laboratories
Ophthalmic · 83d
Cleared May 10, 1999
DRAINAGE WICK
K990671 · HOZ
Hurricane Medical
Ophthalmic · 69d
Cleared May 10, 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · JHI
Sa Scientific, Inc.
Chemistry · 68d