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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168745–168768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1979
ANTI-COCCIDIOIDES SERUM #CF10028X
K791388 · GMH
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
COCCIDIOIDES ANTIGEN #CF10023X
K791389 · GMI
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-BLASTOMYCES SERUM #CF10027X
K791390 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-HISTOPLASMA SERUM #CF10026X
K791392 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA YEAST ANTI #CF10021X
K791393 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
HISTOPLASMA MYCELIAL #CF10020X
K791394 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-HISTOPLASMA SERUM #CF10025X
K791395 · GMK
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
MEDI-TRAK PORTABLE TRACTION DEVICE
K791396 · HST
Medicorp, Inc.
Neurology · 37d
Cleared Aug 16, 1979
GASTRIC LAVAGE KIT-DISPOSABLE
K791400 · GBQ
Acumed Instruments Corp.
General & Plastic Surgery · 31d
Cleared Aug 16, 1979
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · KCT
Anago, Inc.
General Hospital · 20d
Cleared Aug 16, 1979
AMES TDA/TOBRAMYCIN
K791435 · KLB
Miles Laboratories, Inc.
Toxicology · 16d
Cleared Aug 16, 1979
ACE EXTERNAL BONE CLAMP PART #S11
K791466 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 15d
Cleared Aug 16, 1979
VITALOGRAPH FUNCTION ANALYZER
K791503 · BZC
Vitalograph , Ltd.
Anesthesiology · 8d
Cleared Aug 10, 1979
PULSE GENERATOR, R WAVE DEMAND
K790141 · DXY
Pacesetter Systems
Cardiovascular · 203d
Cleared Aug 10, 1979
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · DTD
Pacesetter Systems
Cardiovascular · 192d
Cleared Aug 10, 1979
MDL-201A & T DL-201A PULSE GENERATOR
K790428 · DXY
Pacesetter Systems
Cardiovascular · 162d
Cleared Aug 10, 1979
DENTURE-TIGHT
K790589 · EBP
Den-Mat Corp.
Dental · 136d
Cleared Aug 10, 1979
BRITT LENS COMPUTER
K790694 · IYO
Britt Corp., Inc.
Radiology · 122d
Cleared Aug 10, 1979
A-GENT QUANTICHROM T4 11A
K790848 · KLI
Abbott Laboratories
Chemistry · 99d
Cleared Aug 10, 1979
QUANTIMUNE T-3 FIA
K790960 · CDP
Bio-Rad
Chemistry · 80d
Cleared Aug 10, 1979
CHEMODENT CERAMIC METAL
K791005 · EJS
Chemodent Dental Laboratory
Dental · 72d
Cleared Aug 10, 1979
SCI-PHARM PAINT-ON RESTORATIVE
K791067 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 10, 1979
ANTERIOR/POSTERIOR RESTORATIVE, BOND
K791078 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 10, 1979
LITHICRON MODEL 0401, PACEMAKER
K791095 · DXY
Medcor, Inc.
Cardiovascular · 59d