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
131641–131664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1989
ORAL AIRWAY
K891586 · CAE
Dynarex Corp.
Anesthesiology · 52d
Cleared May 11, 1989
MODEL 2030
K891598 · LNH
Medical Advances, Inc.
Radiology · 52d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891630 · LYY
Inter-Continental Industries Sdn Bhd
General Hospital · 55d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891717 · LYZ
Ulti-Med Intl., Inc.
General Hospital · 51d
Cleared May 11, 1989
MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES
K891775 · EJF
American Orthodontics
Dental · 48d
Cleared May 11, 1989
ARGEDENT 52SF
K891911 · EJT
Argen Precious Metals, Inc.
Dental · 45d
Cleared May 11, 1989
THERMOMAX MICROPLATE READER, MODIFICATION
K892063 · JJQ
Molecular Devices Corp.
Chemistry · 42d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892128 · LYY
Excel U.S.A.
General Hospital · 36d
Cleared May 11, 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
K892235 · LNH
General Electric Co.
Radiology · 37d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892272 · LYY
Wagania Sdn. Bhd.
General Hospital · 36d
Cleared May 11, 1989
PATIENT EXAM GLOVES (MFG. AMERICAN RUBBER PRODUCT)
K892291 · LYY
American Health Products, Inc.
General Hospital · 35d
Cleared May 11, 1989
DRUGS OF ABUSE URINE CALIBRATORS
K892332 · DKB
Hycor Biomedical, Inc.
Toxicology · 36d
Cleared May 11, 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523 · FJI
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared May 11, 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · NAD
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 30d
Cleared May 11, 1989
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535 · HAE
Zinnanti Surgical Instruments, Inc.
Neurology · 30d
Cleared May 11, 1989
TAYLOR SPINAL RETRACTOR
K892546 · HAO
Zinnanti Surgical Instruments, Inc.
Neurology · 30d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892681 · LYY
United States Import Sales
General Hospital · 30d
Cleared May 11, 1989
VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
K892693 · KOH
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 28d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892737 · LYY
Kds Latex Industrial Co., Ltd.
General Hospital · 28d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892738 · LYY
Sung Tai Industrial Co., Ltd.
General Hospital · 28d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892739 · LYY
Yu Cheng Furniture Industrial Co., Ltd.
General Hospital · 28d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892744 · LYY
Chien Lung Rubber Co., Ltd.
General Hospital · 30d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892745 · LYY
Wei Shung Industrial Co., Ltd.
General Hospital · 30d
Cleared May 10, 1989
SILICONE LARYNGEAL STENT
K884810 · FWN
Hood Laboratories
Ear, Nose, Throat · 174d