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
111553–111576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1993
ALDO'S OPTICAL FRAME COLLECTION
K933956 · HQZ
Frontier Novelty, Inc.
Ophthalmic · 67d
Cleared Oct 18, 1993
SPECTACLE FRAMES
K933991 · HQZ
U.S. Optical
Ophthalmic · 62d
Cleared Oct 18, 1993
SPECTACLE SUNGLASSES (NON-PERSCRIPTION)
K934034 · HQY
H.M.O. Optical, Inc.
Ophthalmic · 61d
Cleared Oct 18, 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
K934056 · JJY
Medical Analysis Systems, Inc.
Chemistry · 60d
Cleared Oct 18, 1993
SPECTACLE SUN GLASSES (NON PRESCRIPTION)
K934081 · HQY
South American Optical, Inc.
Ophthalmic · 59d
Cleared Oct 18, 1993
SPECTACLE FRAMES
K934082 · HQZ
South American Optical, Inc.
Ophthalmic · 59d
Cleared Oct 18, 1993
NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES
K934120 · HQY
Lux DE Paris, Inc.
Ophthalmic · 55d
Cleared Oct 15, 1993
MEDSURG CIRCUMCISION TRAY
K920838 · HFK
Medsurg Industries, Inc.
Obstetrics & Gynecology · 599d
Cleared Oct 15, 1993
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 526d
Cleared Oct 15, 1993
MDT/HARVEY MC-8 AND MC-10
K924955 · FLE
Mdt Corp., Inc.
General Hospital · 380d
Cleared Oct 15, 1993
DYLNAMEDICS A.S.A.P.
K924973 · INX
Dynamedics, Inc.
Physical Medicine · 380d
Cleared Oct 15, 1993
DUODERM TRANSPARENT HYDROCOLLOID DRESSING
K925992 · KMK
Convatec, A Division of E.R. Squibb &...
General Hospital · 324d
Cleared Oct 15, 1993
H-220 PRESS-FIT ACETABULAR CUP SYSTEM
K926134 · MEH
Implex Corp.
Orthopedic · 312d
Cleared Oct 15, 1993
ENDOSCOPIC SCISSORS (DISPOSABLE/REUSABLE SHAFTS)
K926203 · GEI
Weck Endoscopy
General & Plastic Surgery · 310d
Cleared Oct 15, 1993
ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE
K926242 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 308d
Cleared Oct 15, 1993
REFLEX ESI
K926297 · GEI
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 305d
Cleared Oct 15, 1993
LAPAROSCOPIC BALLOON RETRACTOR
K926480 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 290d
Cleared Oct 15, 1993
LOW DEAD SPACE ADAPTOR & REUASABLE AIRWAY ADAPTOR
K930250 · CCK
Pryon Corp.
Anesthesiology · 282d
Cleared Oct 15, 1993
LATEX EXAMINATION GLOVE POWDER FREE FORMTEX
K931427 · LYY
Formtex Medical Sdn. Bhd.
General Hospital · 204d
Cleared Oct 15, 1993
INTHERM RADIALLY EXPANDING DILATING INTRODUCER
K931489 · DYB
Innerdyne Medical, Inc.
Cardiovascular · 204d
Cleared Oct 15, 1993
SIME HEALTH SIME HYPOALLERGENIC
K931491 · LYY
Sime Health, Ltd.
General Hospital · 204d
Cleared Oct 15, 1993
ZOLL PD 5300
K931787 · LDD
Zoll Medical Corp
Cardiovascular · 186d
Cleared Oct 15, 1993
CARELET SAFETY LANCET
K931828 · FMK
Gainor Medical Europe, Ltd.
General & Plastic Surgery · 190d
Cleared Oct 15, 1993
MULTILINE
K932156 · GEX
Derma-Lase Co.
General & Plastic Surgery · 164d