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
175921–175944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1976
TEST, C-REATIVE PROTEIN, LATEX SLIDE
K760035 · DCK
Gamma Biologicals, Inc.
Immunology · 50d
Cleared Aug 03, 1976
TEST, LATEX SLIDE, RHEUMATOID FACTOR
K760036 · DHR
Gamma Biologicals, Inc.
Immunology · 50d
Cleared Aug 03, 1976
TEST, MONO., CARD (MACRO-VUE)
K760040 · KTN
Bd Becton Dickinson Vacutainer...
Immunology · 49d
Cleared Aug 03, 1976
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 49d
Cleared Aug 03, 1976
CULTURE TUBE, (VACUTAINER)
K760054 · JTW
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Aug 03, 1976
SPECIMEN COLLECTOR, ANAEROBIC
K760063 · JTX
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Aug 03, 1976
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O
K760096 · GTQ
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
FEBRILE ANTIGENS & CONTROL SERUMS
K760097 · GSZ
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
REAGENT, VDRL
K760098 · GMT
Gamma Biologicals, Inc.
Microbiology · 50d
Cleared Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
K760193 · CIT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
K760194 · CKA
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · CDT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
ASSAY, AMPHET. NDC#11711-0127-1 COULTER
K760196 · DKZ
Coulter Electronics, Inc.
Toxicology · 28d
Cleared Aug 03, 1976
TEST, DETECTION, ANTINUCLEAR ANTIBODIES
K760206 · DHN
Intl. Diagnostic Technology
Immunology · 25d
Cleared Aug 03, 1976
CANNULAE, PLASTIC DISPOSABLE NASAL
K760218 · CAT
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
MASKA, OXYGEN VINYL D-SP. SINGLE USE
K760219 · BYG
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
TUBING, SINGLE USE OXYGEN SUPPLY
K760220 · BYX
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
I.P.P.B., DIS. W/MANIFOLD/NEBULIZER
K760221 · CBO
Manner Medical Products
Anesthesiology · 22d
Cleared Aug 03, 1976
GLOVES, STERILE LATEX SURGEON'S
K760243 · KGO
Travenol Laboratories, S.A.
General Hospital · 18d
Cleared Aug 03, 1976
RADIOASSY KIT, 3H-FOLATE
K760262 · CGN
Diamond Shamrock Corp.
Chemistry · 13d
Cleared Aug 03, 1976
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318 · GFO
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 8d
Cleared Aug 03, 1976
CHAIR, DENTAL OPERATIVE
K760321
The S. S. White Co.
Dental · 8d
Cleared Aug 03, 1976
CHAIR, ATTACHED INSTRUMENT DEL. SYS.
K760322 · KLC
The S. S. White Co.
Dental · 8d
Cleared Aug 03, 1976
X-RAY UNIT, DENTAL DIAGNOSTIC
K760323 · EAP
The S. S. White Co.
Radiology · 8d