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
153361–153384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1984
IRRIGATION, ASPIRATION TUBING SETS
K841072 · HQC
Innovative Surgical Products, Inc.
Ophthalmic · 17d
Cleared Mar 27, 1984
IMAGE DEFLECTOR
K833669 · HPA
Michael Onufryk
Ophthalmic · 161d
Cleared Mar 27, 1984
POROCOAT HPS II HIP PROSTHESIS
K833681 · LPH
Depuy, Inc.
Orthopedic · 147d
Cleared Mar 27, 1984
SHILEY DISPOS. TEMP. PROBES
K833981 · FLL
Shiley, Inc.
General Hospital · 131d
Cleared Mar 27, 1984
PDI PREPMASTER WET PACK PATIENT PREP KIT
K840342 · FRG
Nice-Pak Products, Inc.
General Hospital · 81d
Cleared Mar 27, 1984
PDI PREPMASTER WET PACK VAGINAL-X21477
K840343 · KGO
Nice-Pak Products, Inc.
General Hospital · 81d
Cleared Mar 27, 1984
I.V. START KIT
K840619 · FPA
Marwood Medical, Inc.
General Hospital · 42d
Cleared Mar 27, 1984
PULSELIFE STIMULATOR
K840983 · BWK
Pulse Life, Inc.
Neurology · 21d
Cleared Mar 27, 1984
ACUPUNCTURE INSOLES
K840995 · BWK
Lu LU Enterprise Co. , Ltd.
Neurology · 19d
Cleared Mar 26, 1984
PDI PREPMASTER WET PACK MINOR PROCEDURE
K840344 · FRG
Nice-Pak Products, Inc.
General Hospital · 80d
Cleared Mar 26, 1984
MANNITOL SALT AGAR
K841134 · JSI
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MYCOSEL AGAR W/CHLORAMPHENICOL &
K841135 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
SABOURAUD DEXTROSE AGAR W/CHLORAMPHE
K841136 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MUELLER HINTON AGAR W/WO BLOOD
K841137 · JTZ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COLUMBIA AGAR W/COLISTIN, NALADIXIC
K841139 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
PHENYLETHYL ALCOHOL BLOOD AGAR
K841140 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MACCONKEY AGAR
K841141 · JSI
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COLUMBIA AGAR W/5% SHEEP BLOOD
K841143 · JSG
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
CHOCOLATE AGAR W/COFACTOR
K841144 · JSG
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COMPRESSION STOCKINGS W/WAIST SUSPENS-
K841253
Baurs Krey Assoc., Inc.
General Hospital
Cleared Mar 26, 1984
CSPI ROTARY SURGICAL ASPIRATOR
K841383
Custom Surgical Products, Inc.
Cardiovascular
Cleared Mar 23, 1984
TOBRAMYCIN REAGENT
K832763 · KLB
Biosan Laboratories, Inc.
Chemistry · 220d
Cleared Mar 23, 1984
ACE COLOR TEST
K833933 · KQN
Hana Biologics, Inc.
Chemistry · 130d
Cleared Mar 23, 1984
ERYTHROPOIETIN EIA
K833957 · GGT
Jcl Clinical Research Corp.
Hematology · 128d