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
128137–128160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1989
INFILTRATION PUMP SYRINGE
K894882 · BSP
R. J. Doyle, Inc.
Anesthesiology · 121d
Cleared Nov 30, 1989
SCD KNEE IMMOBILIZER
K895278 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 99d
Cleared Nov 30, 1989
COHERENT HOLMIUM:YAG SURGICAL LASER
K895518 · GEX
Lumenis, Inc.
General & Plastic Surgery · 79d
Cleared Nov 30, 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 50d
Cleared Nov 30, 1989
DEVILBISS MODEL 6300D
K896090 · EPN
Devilbiss Health Care, Inc.
Ear, Nose, Throat · 42d
Cleared Nov 30, 1989
MODIFIED MODEL 535(TM) LUMINOMETER
K896117 · JJQ
Los Alamos Diagnostics
Chemistry · 41d
Cleared Nov 30, 1989
PORGES HOT BIOPSY FORCEPS
K896537 · KGE
Porges Corp.
Gastroenterology & Urology · 15d
Cleared Nov 29, 1989
APEXIT ROOT CANAL SEALER
K893794 · KIF
Williams Dental Co., Inc.
Dental · 191d
Cleared Nov 29, 1989
KRONAMAX KUBE
K893903 · KQX
Physicians Digital Co.
Neurology · 183d
Cleared Nov 29, 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103 · GTZ
Gen-Probe, Inc.
Microbiology · 106d
Cleared Nov 29, 1989
OSSEODENT PROSTHETIC KIT
K895333 · DZE
Celtrix Laboratories
Dental · 90d
Cleared Nov 29, 1989
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · DWF
Kendall Healthcare Products Co....
Cardiovascular · 89d
Cleared Nov 29, 1989
ASPIRETTE ENDOCERVICAL ASPIRATOR
K895403 · HFC
Unimar, Inc.
Obstetrics & Gynecology · 83d
Cleared Nov 29, 1989
TOWER SELF SEAL STERILIZATION POUCH
K895422 · JOJ
Baxter Healthcare Corp
General Hospital · 89d
Cleared Nov 29, 1989
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · DQY
Quinton, Inc.
Cardiovascular · 85d
Cleared Nov 29, 1989
SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD
K895519 · HHD
Personal Products Co.
Obstetrics & Gynecology · 78d
Cleared Nov 29, 1989
SICKLE CELL SOLUBILITY TEST KIT
K895745 · JBB
Simmler, Inc.
Hematology · 64d
Cleared Nov 29, 1989
OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER
K895780 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 63d
Cleared Nov 29, 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · LBS
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Nov 29, 1989
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
K895959 · EKJ
Brevet, Inc.
Dental · 49d
Cleared Nov 29, 1989
IMMUNOCARD STREP A TEST
K896109 · GTZ
Disease Detection International, Inc.
Microbiology · 37d
Cleared Nov 29, 1989
MODIFIED RUBAGEN
K896433 · LQN
Biokit USA, Inc.
Microbiology · 20d
Cleared Nov 28, 1989
MOP CATHETER
K891239 · KDL
Bivona Medical Technologies
Gastroenterology & Urology · 266d
Cleared Nov 28, 1989
LATEX PATIENT EXAMINATION GLOVES
K894713 · LYY
Vailwood Products, L.P.
General Hospital · 127d