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
174961–174984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1976
TABLE, SAMPLE IL 461
K760233 · JJQ
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Aug 26, 1976
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247 · CFR
Sigma Chemical Co.
Chemistry · 38d
Cleared Aug 26, 1976
TEST, MACROGLOBULIN KIT (ALPHA2)
K760396
Kallestad Laboratories, Inc.
Immunology · 20d
Cleared Aug 26, 1976
REAGENT, P-NITROPHENYL PHOSPHATE
K760399 · CJE
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared Aug 26, 1976
COCAINE KIT, TOXI-PAK
K760401 · DLN
J.T. Baker Chemical Co.
Toxicology · 20d
Cleared Aug 26, 1976
TAMPON, PLAYTEX 2 VERSION B
K760426 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 14d
Cleared Aug 26, 1976
NEBULIZER ADAPTER (AERMIST)
K760442 · CAF
Aerway Laboratories, Inc.
Anesthesiology · 10d
Cleared Aug 26, 1976
CARDIAC ELECTRODE
K760443 · DTB
Meadox Medicals, Div. Boston...
Cardiovascular · 10d
Cleared Aug 26, 1976
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON
K760444 · HQB
Varian Assoc., Inc.
Ophthalmic · 10d
Cleared Aug 26, 1976
DENTAL PROPHYLAXIS UNIT ULTRASONIC
K760445 · ELC
Branson Ultrasonics Corp.
Dental · 10d
Cleared Aug 26, 1976
GOUFFON PIN, ADJUSTABLE
K760454 · JDW
Howmedica Corp.
Orthopedic · 10d
Cleared Aug 26, 1976
OBSTETRICAL PACK (VIGILON OB PACK)
K760455 · HHD
C.R. Bard, Inc.
Obstetrics & Gynecology · 10d
Cleared Aug 26, 1976
NOSE CLIP
K760461 · BXJ
Inspiron Corp.
Anesthesiology · 8d
Cleared Aug 26, 1976
TABLE, X-RAY, RFX CLASSICAL
K760466 · IXR
General Electric Co.
Radiology · 8d
Cleared Aug 26, 1976
PLETHYSMOGRAPH (MDI SYSTEM II)
K760504 · JOM
Marketing Development Intl.
Cardiovascular · 3d
Cleared Aug 23, 1976
SYRINGE, DISPOSABLE, ALL PLASTIC
K760004 · FMF
Stewart-Naumann Laboratories
General Hospital · 77d
Cleared Aug 23, 1976
SYRINGE, DISPOSABLE, GLASS & PLASTIC
K760005 · FMF
Stewart-Naumann Laboratories
General Hospital · 77d
Cleared Aug 23, 1976
CATHETER, SILICONE FOLEY (BARDEX)
K760093 · GBM
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Aug 23, 1976
SUCTION INSTRUMENT, MACBICK POOLE TIP
K760216 · GCX
C.R. Bard, Inc.
General Hospital · 42d
Cleared Aug 23, 1976
SUCTION INSTRUMENT, MACBICK DIS. FRAZ.
K760217 · GCX
C.R. Bard, Inc.
General Hospital · 42d
Cleared Aug 23, 1976
OXIMETER, IN VIVO CATHETER
K760234 · DQE
Oximetrix, Inc.
Cardiovascular · 39d
Cleared Aug 23, 1976
RADIOEAR, PERSONAL
K760244 · ESD
Radioear Corp.
Ear, Nose, Throat · 38d
Cleared Aug 23, 1976
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
K760253 · GBM
C.R. Bard, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 23, 1976
TRAY, FOLEY CATHETER
K760254 · GBM
C.R. Bard, Inc.
Gastroenterology & Urology · 35d