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
101041–101064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1995
ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
K936073 · GNM
Chemicon Intl., Inc.
Microbiology · 627d
Cleared Sep 08, 1995
COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
K936089 · GNM
Chemicon Intl., Inc.
Microbiology · 626d
Cleared Sep 08, 1995
COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
K936145 · GNM
Chemicon Intl., Inc.
Microbiology · 620d
Cleared Sep 08, 1995
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
K936251 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
K936252 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
K936253 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
K936254 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
POLIOVIRUS 1 MONOCLONAL ANTIBODY
K940018 · GOE
Light Diagnostics
Microbiology · 612d
Cleared Sep 08, 1995
ENTEROVIRUS 70 MONCLONAL ANTIBODY
K940363 · GOE
Light Diagnostics
Microbiology · 590d
Cleared Sep 08, 1995
COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
K940471 · GNM
Chemicon Intl., Inc.
Microbiology · 583d
Cleared Sep 08, 1995
COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
K940472 · GNM
Chemicon Intl., Inc.
Microbiology · 583d
Cleared Sep 08, 1995
ANALGRAPH
K941801 · KLA
Sandhill Scientific, Inc.
Gastroenterology & Urology · 514d
Cleared Sep 08, 1995
PRESSURE SENSING SCOPE SHEATH SYSTEM
K944553 · HRX
Linvatec Corp.
Orthopedic · 357d
Cleared Sep 08, 1995
GAMBRO LUNDIA 94-500 DIALYZER
K945746 · FJI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 289d
Cleared Sep 08, 1995
GAMBRO LUNDIA 94-600 DIALYZER
K945747 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 289d
Cleared Sep 08, 1995
REDDY ILLUMINATOR
K950960 · FFS
Luxtec Corp.
Gastroenterology & Urology · 190d
Cleared Sep 08, 1995
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · HCG
Target Therapeutics
Neurology · 171d
Cleared Sep 08, 1995
INNOVASIVE DEVICES ROTATOR CUFF FASTENER
K951565 · MBI
Innovasive Devices, Inc.
Orthopedic · 157d
Cleared Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 155d
Cleared Sep 08, 1995
OSTEONICS SPINAL SYSTEM
K951725 · MNH
Osteonics Corp.
Orthopedic · 147d
Cleared Sep 08, 1995
LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE
K951990 · GCJ
Schoelly Technologies, Inc.
General & Plastic Surgery · 134d
Cleared Sep 08, 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251 · JJX
Diagnostic Products Corp.
Chemistry · 116d
Cleared Sep 08, 1995
ADP REAGENT, MODIFIED
K952252 · GHR
Helena Laboratories
Hematology · 116d
Cleared Sep 08, 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 116d