FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
110809–110832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1993
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · KNQ
Olympus Corp.
Gastroenterology & Urology · 126d
Cleared Dec 21, 1993
QUANTA LITE(TM) HISTONE ELISA
K934053 · LLL
Inova Diagnostics, Inc.
Immunology · 124d
Cleared Dec 21, 1993
THAYER MARTIN, MODIFIED PILL POCKET
K934331 · JTY
Hardy Diagnostics
Microbiology · 109d
Cleared Dec 21, 1993
CONTACT LENSES
K934859 · HPC
Arno Intl., Inc.
Ophthalmic · 70d
Cleared Dec 20, 1993
AESCULAP RIGID ENDOSCOPES
K933834 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 137d
Cleared Dec 17, 1993
MODEL 508 PATIENT MONITOR
K921309 · BTY
Criticare Systems, Inc.
Anesthesiology · 647d
Cleared Dec 17, 1993
POLYVIOLENE SUTURE-REVISED LABELING
K926167 · GAT
Look, Inc.
General & Plastic Surgery · 381d
Cleared Dec 17, 1993
SILK SUTURES-REVISED LABELING
K926168 · GAR
Look, Inc.
General & Plastic Surgery · 381d
Cleared Dec 17, 1993
ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
K926181 · GCJ
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 374d
Cleared Dec 17, 1993
REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
K926587 · GAR
Look, Inc.
General & Plastic Surgery · 381d
Cleared Dec 17, 1993
REVISED LABELING FOR POLYPROPYLENE SUTURE
K926588 · GAW
Look, Inc.
General & Plastic Surgery · 381d
Cleared Dec 17, 1993
SUTURES
K930360 · GAM
Ethicon, Inc.
General & Plastic Surgery · 325d
Cleared Dec 17, 1993
NON-ABSORBABLE SURGICAL SUTURES
K930517 · GAR
Alcon Laboratories
General & Plastic Surgery · 319d
Cleared Dec 17, 1993
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
K930586 · GAR
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
SURGILENE POLYPROPYLENE SUTURE
K930587 · GAW
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
K930589 · GAL
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
SILK SUTURES
K930590 · GAT
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
TI-CRON AND DACRON SUTURES
K930591 · GAT
Davis & Geck, Inc.
General & Plastic Surgery · 316d
Cleared Dec 17, 1993
LUKENS STAINLESS STEEL SURGICAL SUTURE
K930940 · GAQ
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE
K930941 · GAW
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
LUKENS SILK SURGICAL SUTURE
K930942 · GAT
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
LUKENS NYLON SURGICAL SUTURE
K930943 · GAR
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
LUKENS SURGICAL GUT SUTURE
K930944 · GAL
Lukens Medical Corp.
General & Plastic Surgery · 297d
Cleared Dec 17, 1993
BRAIDED POLYESTER SURGICAL SUTURE
K930945 · GAT
Lukens Medical Corp.
General & Plastic Surgery · 297d