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
127465–127488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1990
THORA-KLEX CHEST DRAINAGE UNIT
K896127 · KDQ
Davol, Inc.
General Hospital · 93d
Cleared Jan 24, 1990
URETHRAL CATHETERIZATION TRAYS
K896212 · FCM
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 90d
Cleared Jan 24, 1990
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · JOP
Millar Instruments, Inc.
Cardiovascular · 85d
Cleared Jan 24, 1990
MODEL EC4542G MINIATURE
K896352 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Jan 24, 1990
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
K896427 · CCL
Spacelabs, Inc.
Anesthesiology · 77d
Cleared Jan 24, 1990
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
K896664 · CAK
Asahi Medical Co., Ltd.
General Hospital · 61d
Cleared Jan 24, 1990
MODIFIED ANGIOGRAPHIC CATHETER
K896690 · DQO
Novoste Corp.
Cardiovascular · 57d
Cleared Jan 24, 1990
PISTON SYRINGE
K896722 · FMF
Safe Tech Medical Products, Inc.
General Hospital · 57d
Cleared Jan 24, 1990
SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM
K896847 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 50d
Cleared Jan 24, 1990
LATEXINDO LATEX EXAMINATION GLOVES
K896906 · LYY
P.T. Latexindo Sejahtera
General Hospital · 47d
Cleared Jan 24, 1990
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
K896976 · CAK
Asahi Medical Co., Ltd.
General Hospital · 42d
Cleared Jan 24, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · LJM
General Biometrics, Inc.
Immunology · 19d
Cleared Jan 24, 1990
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER
K900160 · KQM
Jedmed Instrument Co.
General & Plastic Surgery · 12d
Cleared Jan 24, 1990
4/1 ARMBOARD
K900175 · BTX
Infection Control Products, Inc.
General & Plastic Surgery · 12d
Cleared Jan 23, 1990
SEAMLESS LATEX PATIENT EXAMINATION GLOVES
K891490 · LYY
Med-Care Sdn. Bhd.
General Hospital · 313d
Cleared Jan 23, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892307 · LYY
Guangming Latex Factory
General Hospital · 292d
Cleared Jan 23, 1990
EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)
K893025 · LYY
Wen Hao, Inc.
General Hospital · 286d
Cleared Jan 23, 1990
BESTONE MODEL ITE & CANAL
K893887 · ESD
Bestone Hearing Instruments
Ear, Nose, Throat · 238d
Cleared Jan 23, 1990
AE-105D DIAGNOSTIC TYMPANOMETER
K894260 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 217d
Cleared Jan 23, 1990
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
K894888 · JAK
Shimadzu Medical Systems
Radiology · 175d
Cleared Jan 23, 1990
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K895310 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 147d
Cleared Jan 23, 1990
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · HIS
Armkel, LLC
Obstetrics & Gynecology · 126d
Cleared Jan 23, 1990
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 78d
Cleared Jan 23, 1990
R-150-ET COLLIMATOR
K896486 · IZX
Advantech
Radiology · 71d