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
172753–172776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780005 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780006 · GNS
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780007 · GQQ
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GOAT ANTI-INFLUENZA ANTISERA
K780008 · GQT
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
GUINEA PIG WHOLE SERUM
K780009 · KIS
Northeast Biomedical Labs., Inc.
Pathology · 17d
Cleared Jan 20, 1978
GOAT ANTI-RUBELLA ANTISERA
K780010 · GOK
Northeast Biomedical Labs., Inc.
Microbiology · 17d
Cleared Jan 20, 1978
ANTITHROMBIN III RIA
K780012 · DDQ
Ria Diagnostics
Hematology · 17d
Cleared Jan 20, 1978
CULTURE MEDIA/ISOLA. PATHO. NEISSERIA
K780022 · JTY
Diagnostic Culture System
Microbiology · 16d
Cleared Jan 20, 1978
FLUORESCENCE DETECTOR MODEL 420
K780031 · KHO
Waters Assoc., Inc.
Toxicology · 11d
Cleared Jan 20, 1978
DENTAL HANDPIECE
K780038 · EFB
Lares Manufacturing Co., Inc.
Dental · 11d
Cleared Jan 20, 1978
AMINOGLYCOSIDE TEST SYSTEM
K780048 · DID
Nichols Institute Diagnostics
Immunology · 11d
Cleared Jan 20, 1978
PROSTHESIS, DOUBLE CUP
K780052 · JDI
Depuy, Inc.
Orthopedic · 11d
Cleared Jan 20, 1978
RUBENOSTICON
K780063 · GOK
Organon, Inc.
Microbiology · 8d
Cleared Jan 20, 1978
HEARING AID, BEHIND-THE-EAR
K780067 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 8d
Cleared Jan 17, 1978
INSPIRON MANIFOLD (DOUBLE)
K772294 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
INSPIRON MANIFOLD (SINGLE)
K772295 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
INSPIRON MANIFOLD
K772296 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jan 17, 1978
DENTAL LIGHT
K772351 · EAZ
Chemetron Dental Products
Dental · 26d
Cleared Jan 17, 1978
PULSE GENERATORS
K772357 · DXY
Medtronic Vascular
Cardiovascular · 21d
Cleared Jan 17, 1978
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
K772370 · EPY
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
ROLLER KNIFE
K772372 · JYO
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
HILDYARD POST NASAL FORCEP
K772377 · KAE
Edward Weck, Inc.
Ear, Nose, Throat · 21d
Cleared Jan 17, 1978
FARRIOR OVAL SPECULUM
K772380 · EPY
Edward Weck, Inc.
General & Plastic Surgery · 21d
Cleared Jan 17, 1978
RING HANDLE & RETRACTORS
K772381 · KAL
Edward Weck, Inc.
Ear, Nose, Throat · 21d