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
159889–159912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1982
OXY-PMMA
K821866 · HPX
Petrarch Systems & Professional Pharm
Ophthalmic · 82d
Cleared Sep 14, 1982
ZIMMER METAL BACKED ACETABULAR CUP
K821893 · JDI
Zimmer, Inc.
Orthopedic · 78d
Cleared Sep 14, 1982
NAGASHIMA SN-SP UNIT AND CHAIR
K822016 · ETF
Kelleher Corp.
Ear, Nose, Throat · 68d
Cleared Sep 14, 1982
DIAGLAZE
K822142 · EJR
Antraco, Inc.
Dental · 56d
Cleared Sep 14, 1982
RE1000 HEART RATE MONITOR
K822319 · DRT
Electronic Monitors, Inc.
Cardiovascular · 42d
Cleared Sep 14, 1982
POWDER BLOWERS
K822351 · KMA
Kelleher Corp.
Ear, Nose, Throat · 39d
Cleared Sep 14, 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418 · CHH
Emd Chemicals, Inc.
Chemistry · 34d
Cleared Sep 14, 1982
SELF-CONTAINED MOBILE OPHTHAL. OPER. .
K822427 · FSE
Surgi-Quip Inc.U
General & Plastic Surgery · 33d
Cleared Sep 14, 1982
HCT CENTRIFUGE
K822445 · GKG
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Sep 14, 1982
SCISSORS, VARIOUS
K822448 · FZT
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 29d
Cleared Sep 14, 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 29d
Cleared Sep 14, 1982
VISIO-OPAQUER
K822453 · EBF
Espe GmbH (Us)
Dental · 29d
Cleared Sep 14, 1982
YEAST AUTOLYXATE SUPPLEMENT
K822458 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
VCAT ANTIBIOTIC SUPPLEMENT
K822459 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
LCAT ANTIBIOTIC SUPPLEMENT
K822460 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
N-S ANAEROBE SUPPLEMENT
K822461 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
G-N ANAEROBE SUPPLEMENT
K822462 · JSK
Oxoid U.S.A., Inc.
Microbiology · 29d
Cleared Sep 14, 1982
ENZYMUNE SYSTEM I
K822465 · JJE
Icl Scientific
Chemistry · 29d
Cleared Sep 14, 1982
THROMBIN TIME TEST
K822466 · GJA
American Dade
Hematology · 29d
Cleared Sep 14, 1982
PSI TOTAL PROTEIN REAGENT
K822468 · CEK
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI CALCIUM REAGENT
K822469 · CIC
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI INORGANIC PHOSPHORUS
K822470 · CEO
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
PSI ALBUMIN REAGENT
K822471 · CIX
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Sep 14, 1982
CHOLESTEROL STANDARD #65077
K822474 · JIS
Emd Chemicals, Inc.
Chemistry · 28d