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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130825–130848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1989
MINI-DIAMOND KNIFE
K893033 · GDX
L.A.B. Instruments
General & Plastic Surgery · 32d
Cleared May 26, 1989
SPINALATOR JS-1100 TRACTION UNIT
K893168 · ITH
The Spinalator Co.
Physical Medicine · 42d
Cleared May 26, 1989
ALPHA MALLARD
K893248 · INI
Alpha Unlimited, Inc.
Physical Medicine · 28d
Cleared May 25, 1989
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
K885139 · BTO
Pertrach
Anesthesiology · 161d
Cleared May 25, 1989
OXITRON OXYGEN SENSOR
K890144 · CCL
Oxitron Medical Products
Anesthesiology · 132d
Cleared May 25, 1989
INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES
K891105 · GXY
Acudata Software
Neurology · 84d
Cleared May 25, 1989
INDICATENS INDICATOR ELECTRODE MODEL 2
K891107 · GXY
Acudata Software
Neurology · 84d
Cleared May 25, 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · CAW
Invacare Corp.
Anesthesiology · 69d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891661 · LYY
Dmp, Inc.
General Hospital · 66d
Cleared May 25, 1989
LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)
K891728 · LYY
Baldur Systems Corp.
General Hospital · 63d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891736 · LYY
Quest Intl., Inc.
General Hospital · 64d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891864 · LYY
Pt Latexindo Lestari
General Hospital · 59d
Cleared May 25, 1989
NIL (PATIENT EXAMINATION GLOVES - LATEX)
K891865 · LYY
Medicare Industries, Inc.
General Hospital · 59d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891881 · LYY
Cymun Development Sdn Bhd
General Hospital · 58d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891949 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 58d
Cleared May 25, 1989
YUPOND LATEX EXAMINATION GLOVES
K891959 · LYY
Yupond Ent. Co., Ltd.
General Hospital · 57d
Cleared May 25, 1989
PATIENT EXAM GLOVES (MFG. YU HUA LATEX FACTORY)
K892022 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 56d
Cleared May 25, 1989
PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX )
K892023 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 56d
Cleared May 25, 1989
PATIENT EXAM GLOVES (MFG. CHAGAN TANG CAPITOL)
K892024 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 56d
Cleared May 25, 1989
PATIENT EXAM GLOVES (MFG. BEIJING LATEX FACTORY)
K892025 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 56d
Cleared May 25, 1989
PROLAX PATIENT EXAMINATION GLOVES (LATEX)
K892026 · LYY
Ergo Intl., Ent., Inc.
General Hospital · 56d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892111 · LYY
Maika Holdings Sdn. Bhd.
General Hospital · 52d
Cleared May 25, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892304 · LYY
Saraf Chemicals Pvt. , Ltd.
General Hospital · 49d
Cleared May 25, 1989
PERRY* NON-STERILE X-AM* GLOVES
K892353 · LYY
Smith & Nephew Medical
General Hospital · 71d