Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
169585–169608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1979
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
K791382 · GMD
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
CANDIDA IMMUNODIFFUSION KIT #CA1001
K791383 · GMI
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
FUNGAL IMMUNODIFFUSION KIT #ID1001
K791384 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
NEGATIVE CONTROL SERUM FOR CF RO ID
K791385 · GSN
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
K791386 · KFG
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
K791387 · JWT
Immuno-Mycologics, Inc.
Microbiology · 36d
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