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
71137–71160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY...
K024303 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 191d
Cleared Jul 03, 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · POV
Bioshaf , Ltd.
Hematology · 188d
Cleared Jul 03, 2003
FASTPACK FREE T4 IMMUNOASSAY
K030329 · CEC
Qualigen, Inc.
Chemistry · 153d
Cleared Jul 03, 2003
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND...
K030919 · NLR
Medisiss
Gastroenterology & Urology · 101d
Cleared Jul 03, 2003
CARBON FIBER BRIDGE, MODEL 28757
K031070 · EBI
Nobel Biocare AB
Dental · 90d
Cleared Jul 03, 2003
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL...
K031133 · GEI
Surgrx, Inc.
General & Plastic Surgery · 85d
Cleared Jul 03, 2003
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
K031193 · LPN
Alcon, Inc.
Ophthalmic · 78d
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS...
K031422 · DPS
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2003
STAND OUT
K031484 · ELW
Kerr Corp.
Dental · 52d
Cleared Jul 03, 2003
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K031623 · FZP
Coalescent Surgical
General & Plastic Surgery · 41d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 03, 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · NBW
Medline Industries, Inc.
Chemistry · 17d
Cleared Jul 02, 2003
READI-STRAND, MODEL PSSTRAND
K023179 · KXK
Worldwide Medical Technologies, LLC
Radiology · 281d
Cleared Jul 02, 2003
SECQUIRE CELL SEPARATOR
K024080 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 204d
Cleared Jul 02, 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191 · BZD
Resmed, Ltd.
Anesthesiology · 194d
Cleared Jul 02, 2003
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K024307 · IMI
Sybaritic, Inc.
Physical Medicine · 190d
Cleared Jul 02, 2003
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE...
K030113 · DJG
Branan Medical Corp.
Toxicology · 170d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899 · DCN
Abbott Laboratories
Chemistry · 100d
Cleared Jul 02, 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · KWQ
Synthes (Usa)
Orthopedic · 71d
Cleared Jul 02, 2003
PERSONAL DIGITAL WORKSTATION (PDW)
K031372 · LLZ
Maxxvision, LLC
Radiology · 63d
Cleared Jul 02, 2003
OPTIBOND FL
K031444 · KLE
Kerr Dental Materials Center
Dental · 56d
Cleared Jul 02, 2003
FILL-IN
K031476 · EBG
Sybron Dental Specialties, Inc.
Dental · 54d
Cleared Jul 02, 2003
MICROHEATER
K031478 · BSB
Belmont Instrument Corp.
Hematology · 51d
Cleared Jul 02, 2003
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688 · DTL
Guidant Corporation
Cardiovascular · 30d