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
108865–108888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1994
JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
K925468 · GJE
J.J. Skinner, Inc.
Chemistry · 529d
Cleared Apr 11, 1994
LOS 3D VISION 100
K930965 · GCJ
Laser Optik Systeme GmbH & Co. KG
General & Plastic Surgery · 411d
Cleared Apr 11, 1994
LAPRO-LOADER(TM)
K932689 · HET
Surgimark, Inc.
Obstetrics & Gynecology · 312d
Cleared Apr 11, 1994
BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN
K932731 · FYE
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 308d
Cleared Apr 11, 1994
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · KCT
Maxxim Medical
General Hospital · 263d
Cleared Apr 11, 1994
SUNGLASS GALLERY INC. SUNGLASS
K934407 · HQY
Sunglass Gallery, Inc.
Ophthalmic · 214d
Cleared Apr 11, 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · KKX
Storz Instrument Co.
General Hospital · 210d
Cleared Apr 11, 1994
BARRIER FABRIC 450 SURGICAL GOWN
K934608 · FYA
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Apr 11, 1994
SUCTION SET, TRACHAEL
K935583 · BSY
Puritas Health Care, Inc.
Anesthesiology · 144d
Cleared Apr 11, 1994
CURITY FAST-CATH FEMALE CATHETER KIT
K935774 · EYT
Kendall Healthcare Products Co....
Gastroenterology & Urology · 129d
Cleared Apr 11, 1994
ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
K936155 · HIF
Micromedical Devices, Inc.
Obstetrics & Gynecology · 105d
Cleared Apr 11, 1994
EYEGLASS FRAMES (PLASTIC)
K940411 · HQZ
Value Line Optical Services, Inc.
Ophthalmic · 74d
Cleared Apr 11, 1994
E.M.A.
K940612 · HQY
European Manufacturers Agency, Inc.
Ophthalmic · 56d
Cleared Apr 11, 1994
NONE-GENERIC
K940726 · HQY
Jay-Y Enterprises Co., Inc.
Ophthalmic · 52d
Cleared Apr 11, 1994
NON-PRESCRIPTION SUNGLASSES
K940806 · HQY
Top Fashion Optical & Sunglasses
Ophthalmic · 48d
Cleared Apr 11, 1994
WENZHOU IMPORT/EXPORT CORP. NON-PRESCRIPT SUNGLASSES
K940828 · HQY
Rainbow Merchandise, Inc.
Ophthalmic · 48d
Cleared Apr 11, 1994
REWINNER ENT CO. LTD. NON-PRESCRIPTION SUNGLASSES
K940830 · HQY
Rainbow Merchandise, Inc.
Ophthalmic · 48d
Cleared Apr 11, 1994
DAY SUN INDUSTRIAL CORP
K940944 · HQY
Day Sun Industrial Corp.
Ophthalmic · 42d
Cleared Apr 11, 1994
RIO EYEWEAR, PANAMA JACK ENVIRONMENT OPTICS, AND PARADISE RESORT EYEWEAR
K940956 · HQY
Rio Eyewear Group, Inc.
Ophthalmic · 41d
Cleared Apr 11, 1994
MURDOCH LAPAROSCOPE LENS CLEANER
K941092 · GCJ
Cook, Inc.
General & Plastic Surgery · 34d
Cleared Apr 11, 1994
RAE II TRACHEAL TUBE
K941246 · BTR
Mallinckrodt Medical
Anesthesiology · 27d
Cleared Apr 08, 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · FLL
Deroyal Industries, Inc.
General Hospital · 508d
Cleared Apr 08, 1994
ENCOMPAS COMFORT BLOCK # 0B-10
K933537 · MNK
Encompas Unlimited, Inc.
Gastroenterology & Urology · 261d
Cleared Apr 08, 1994
SLT REFLECTING PROBE
K934209 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 221d