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
133081–133104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1989
ROCKET SEX CRIME KIT
K883805 · FMC
A & A Medical, Inc.
General Hospital · 146d
Cleared Jan 31, 1989
MODIFIED 7 INCH CONTINUOUS INFUSION SETS
K884102 · FPA
Quinton, Inc.
General Hospital · 144d
Cleared Jan 31, 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 92d
Cleared Jan 31, 1989
THE ORTHORANGER II ELECTRONIC GONIOMETER
K884611 · KQX
Medical Instruments Technology, Inc.
Neurology · 88d
Cleared Jan 31, 1989
VISI-WIPE
K884924 · HOF
Visitec Co.
Ophthalmic · 64d
Cleared Jan 31, 1989
TRUDELL BENT CATHETER
K885167 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 49d
Cleared Jan 31, 1989
16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR
K885202 · KOD
Coeur Laboratories, Inc.
Gastroenterology & Urology · 46d
Cleared Jan 31, 1989
WINGED INFUSION SET
K885264 · FPA
E-Z-Em, Inc.
General Hospital · 40d
Cleared Jan 31, 1989
QUIK-DOT ANTISTREPTOLYSIN-O
K890025 · GTQ
Ampcor, Inc.
Microbiology · 27d
Cleared Jan 31, 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 21d
Cleared Jan 31, 1989
H-3000 OXYGEN CONCENTRATOR
K890150 · CAW
Healthdyne, Inc.
Anesthesiology · 18d
Cleared Jan 31, 1989
HYDROTONE I
K890308 · ILJ
Hydrotonics Therapy Corp.
Physical Medicine · 8d
Cleared Jan 30, 1989
BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
K875130 · HRX
Orthopedic Systems, Inc.
Orthopedic · 412d
Cleared Jan 30, 1989
MINICAP TM 100 CAPNOMETER
K883090 · CCK
Minesafety Appliances Co.
Anesthesiology · 192d
Cleared Jan 30, 1989
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430 · LCX
Disease Detection International, Inc.
Chemistry · 168d
Cleared Jan 30, 1989
MERIT HI-FLEX(TM)
K883718 · FPK
Merit Medical Systems, Inc.
General Hospital · 152d
Cleared Jan 30, 1989
HUMERAL LOCKING NAIL SYSTEM
K883882 · JDS
Howmedica Corp.
Orthopedic · 139d
Cleared Jan 30, 1989
DRIPRIDE PROVIDE SLIM
K883894 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 138d
Cleared Jan 30, 1989
DRIPRIDE ULTRA INCONTINENT PAD
K883895 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 138d
Cleared Jan 30, 1989
CDI(R) 2000 BLOOD GAS MONITOR
K884228 · CBZ
Cardiovascular Devices, Inc.
Anesthesiology · 115d
Cleared Jan 30, 1989
QUADROJECT(TM)
K884233 · FMF
Ellis Pharmaceutical Consulting, Inc.
General Hospital · 115d
Cleared Jan 30, 1989
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 84d
Cleared Jan 30, 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Jan 30, 1989
ACA DU PONT METHOTREXATE (MTHO) METHOD
K884744 · LAO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d