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
85825–85848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 10, 1999
SAS ONE-STEP PREGNANCY
K990741 · JHI
Sa Scientific, Inc.
Chemistry · 63d
Cleared May 10, 1999
ATLAST GLUCOSE CONTROL SOLUTION
K991075 · JJX
Amira Medical, Inc.
Chemistry · 40d
Cleared May 10, 1999
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
K991369 · LCX
Germaine Laboratories, Inc.
Chemistry · 20d
Cleared May 07, 1999
TTCGHI-T AND TTCTN3-T-T
K982451 · KLW
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 296d
Cleared May 07, 1999
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR,...
K983039 · DYB
Schneider/Namic
Cardiovascular · 249d
Cleared May 07, 1999
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND...
K990507 · KPO
Althin Biopharm, Inc.
Gastroenterology & Urology · 78d
Cleared May 07, 1999
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · NFB
Salter Labs
Anesthesiology · 66d
Cleared May 07, 1999
FLOW LINE
K990756 · EBF
Heraeus Kulzer, Inc.
Dental · 60d
Cleared May 07, 1999
STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS...
K991436 · DZE
Sterngold
Dental · 11d