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
131377–131400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1989
MAYTEX LATEX EXAMINATION GLOVES
K892183 · LYY
Maytex Corp.
General Hospital · 56d
Cleared May 31, 1989
ENDO-SPONGE
K892218 · MNL
Endovations
Gastroenterology & Urology · 58d
Cleared May 31, 1989
NON-STERILE EXAM GLOVES
K892325 · LYY
Ansell, Inc.
General Hospital · 58d
Cleared May 31, 1989
LEONARD TUBE
K892334 · KDH
Surgidyne, Inc.
Gastroenterology & Urology · 56d
Cleared May 31, 1989
ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI.
K892335 · EJT
Argen Precious Metals, Inc.
Dental · 56d
Cleared May 31, 1989
KENDALL CURITY SUCTION CATHETERS
K892441 · BSY
The Kendal Co.
Anesthesiology · 51d
Cleared May 31, 1989
MAYTEX NON-STERILE LATEX EXAM GLOVE
K892557 · LYY
American Seal Co.
General Hospital · 51d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892558 · LYY
National Trading Corp.
General Hospital · 51d
Cleared May 31, 1989
SUNNYTEX LATEX EXAMINATION GLOVES
K892577 · LYY
Glen Nevis Co.
General Hospital · 51d
Cleared May 31, 1989
PATIENT EXAM GLOVES (VINYL) MFG. PRECIOUS MOUNTAIN
K892673 · LYZ
T.C. Electronics Co.
General Hospital · 50d
Cleared May 31, 1989
PATIENT EXAM GLOVES (LATEX) MFG. ADVANCE RUBBER
K892675 · LYY
T.C. Electronics Co.
General Hospital · 50d
Cleared May 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892962 · LYY
Hung Hsien Industrial Co., Ltd.
General Hospital · 49d
Cleared May 31, 1989
OMRON TRAVEL MASSAGER, MODEL HM-01
K893029 · ISA
Omron Electronics, Inc.
Physical Medicine · 37d
Cleared May 30, 1989
URODEC 500
K890284 · FES
Ferguson Medical
Gastroenterology & Urology · 131d
Cleared May 30, 1989
ESPE CAPMIX
K891064 · EFD
Espe GmbH (Us)
Dental · 90d
Cleared May 30, 1989
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · BSS
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 85d
Cleared May 30, 1989
VASCULAR ACCESS PORT CONTINUOUS INFUSION SET
K891226 · FPA
Infucare Products, Inc.
General Hospital · 84d
Cleared May 30, 1989
ARGEDENT 52 (DENTAL ALLOY)
K891989 · EJT
Argen Precious Metals, Inc.
Dental · 63d
Cleared May 30, 1989
NEEDLEPOINT GUARD
K892405 · FMF
Urological Assoc. of Grand Island, P.C.
General Hospital · 53d
Cleared May 26, 1989
GENESIS TM FETAL SYSTEM
K882084 · HGM
Pediatric Diagnostic Service
Obstetrics & Gynecology · 373d
Cleared May 26, 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794 · LWJ
Protek, Inc.
Orthopedic · 261d
Cleared May 26, 1989
ACUDATA INDICATENS MODEL 5X
K890088 · GZJ
Acudata Software
Neurology · 136d
Cleared May 26, 1989
JUMPER PACK #203
K890825 · HQC
O.R. Specialties, Inc.
Ophthalmic · 98d
Cleared May 26, 1989
ESPE TULUX-CEM
K891020 · EBF
Espe GmbH (Us)
Dental · 87d