FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
111697–111720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1993
BRAIDED POLYESTER SURGICAL SUTURE
K930945 · GAT
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
FLEXON AND STAINLESS STEEL SUTURES
K930992 · GAQ
American Cyanamid Co.
General & Plastic Surgery · 295d
Cleared Dec 17, 1993
NYLAMID SUTURE
K931612 · GAR
S. Jackson, Inc.
General & Plastic Surgery · 260d
Cleared Dec 17, 1993
SUPRAMID SUTURE
K931613 · GAR
S. Jackson, Inc.
General & Plastic Surgery · 260d
Cleared Dec 17, 1993
MOPYLEN SUTURE
K931614 · GAW
S. Jackson, Inc.
General & Plastic Surgery · 260d
Cleared Dec 17, 1993
ULTRABRONZ SERIES 400 TANNING BED
K931660 · LEJ
Eurocut, Ltd.
General & Plastic Surgery · 256d
Cleared Dec 17, 1993
ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED
K931661 · LEJ
Eurocut, Ltd.
General & Plastic Surgery · 256d
Cleared Dec 17, 1993
PFM PROFESSIONAL 7000 SPIROMETER
K932278 · BTY
Advanced Medical Systems, Inc.
Anesthesiology · 219d
Cleared Dec 17, 1993
SIGMA BUN REAGENT
K933679 · LFP
Sigma Chemical Co.
Chemistry · 142d
Cleared Dec 17, 1993
SIGMA CO2 ALKALINE BUFFER REAGENT
K933691 · JFL
Sigma Chemical Co.
Chemistry · 141d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE
K934021 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER
K934022 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE
K934023 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE
K934024 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE
K934025 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP. BOWEL GRASPER DEVICE
K934026 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE
K934027 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 122d
Cleared Dec 17, 1993
PHX TECHNOLOGIES CORP.,10MM STERILE, DISPOSABLE POOL TIP SUCTION CANNULA
K934078 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 119d
Cleared Dec 17, 1993
TRANSGROW
K934330 · JTY
Hardy Diagnostics
Microbiology · 105d
Cleared Dec 17, 1993
I-STAT IONIZED CALCIUM TEST
K934642 · JFP
I-Stat Corp.
Chemistry · 87d
Cleared Dec 17, 1993
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · FJK
Baxter Healthcare Corp
Gastroenterology & Urology · 58d
Cleared Dec 17, 1993
EMDS PHOSPHOROUS (PHOS) TEST
K935178 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 17, 1993
URINE METER
K935578 · EXR
Puritas Health Care, Inc.
Gastroenterology & Urology · 29d