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
131065–131088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952 · LZO
Protek, Inc.
Orthopedic · 162d
Cleared May 10, 1989
INTRAFORM TOTAL HIP SYSTEM
K890742 · JDI
Orthomet, Inc.
Orthopedic · 86d
Cleared May 10, 1989
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · IYO
Boston Scientific Corp
Radiology · 84d
Cleared May 10, 1989
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
K891086 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared May 10, 1989
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
K891240 · CIG
Catachem, Inc.
Chemistry · 64d
Cleared May 10, 1989
NICKLE-TITANIUM ORTHODONTIC WIRE
K891327 · FJF
American Orthodontics
Gastroenterology & Urology · 61d
Cleared May 10, 1989
CERUMEN FILTER
K891594 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 51d
Cleared May 10, 1989
RUBBER DAM CLAMPS/FORCEPS
K892261 · EKJ
Zinnanti Surgical Instruments, Inc.
Dental · 36d
Cleared May 10, 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337 · ESD
Qualitone
Ear, Nose, Throat · 35d
Cleared May 09, 1989
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · HQC
CooperVision, Inc.
Ophthalmic · 90d
Cleared May 09, 1989
PENT CAPS
K890662 · EJJ
Jeneric/Pentron, Inc.
Dental · 89d
Cleared May 09, 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · CGX
Hichem Diagnostics
Chemistry · 89d
Cleared May 09, 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · DHB
Pharmacia, Inc.
Immunology · 67d
Cleared May 09, 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · CGS
Trace Scientific , Ltd.
Chemistry · 55d