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
132481–132504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1989
LACEY POSTERIOR STABILIZED KNEE SYSTEM
K884338 · JWH
Dow Corning Wright
Orthopedic · 110d
Cleared Feb 01, 1989
EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
K884614 · DQA
Edentec Corp.
Anesthesiology · 89d
Cleared Feb 01, 1989
MVL/MODULAB WITH PVR MODULE
K884624 · JOM
Life Sciences Manufacturing, Inc.
Cardiovascular · 89d
Cleared Feb 01, 1989
CATH-FINDER SYSTEM
K884701 · FOZ
Pharmacia Deltec, Inc.
General Hospital · 84d
Cleared Feb 01, 1989
MICROVASIVE GOLD PROBE
K885005 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 62d
Cleared Feb 01, 1989
COI 24 HR COLLAGEN SHIELD
K885016 · MOE
Chiron Ophthalmics
Ophthalmic · 58d
Cleared Jan 31, 1989
CUDDLE UP PILLOW
K882544 · FRP
Ohio Medical Instrument Co., Inc.
General Hospital · 224d
Cleared Jan 31, 1989
URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450
K882714 · EYZ
Lsl Industries, Inc.
Gastroenterology & Urology · 214d
Cleared Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · LFX
Organon Teknika Corp.
Microbiology · 197d
Cleared Jan 31, 1989
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS
K883748 · FJI
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 152d
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