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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112873–112896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1993
CHAD LABS ADHESIVE BANDAGE REMOVER
K931933 · KOX
Chad Labs Corp.
General & Plastic Surgery · 80d
Cleared Jul 08, 1993
CHARISMA -- MODIFIED
K932013 · EBF
Heraeus Kulzer, Inc.
Dental · 76d
Cleared Jul 08, 1993
G-CERA ORBIT COLOUR COMMUNICATION SET
K932039 · EIH
GC America, Inc.
Dental · 72d
Cleared Jul 08, 1993
FREEDOM PLUS (CODE NAME MISC-LIB-013)
K932130 · EJT
J.F. Jelenko & Co., Inc.
Dental · 66d
Cleared Jul 08, 1993
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
K932175 · ESD
Phonak, Inc.
Ear, Nose, Throat · 64d
Cleared Jul 08, 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · JHI
Pb Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Jul 08, 1993
RAE(R) II TRACHEAL TUBE
K932280 · BTR
Mallinckrodt Medical
Anesthesiology · 57d
Cleared Jul 08, 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · DIF
Bio-Rad
Toxicology · 36d
Cleared Jul 07, 1993
LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
K915273 · LJT
Strato Medical Corp.
General Hospital · 590d
Cleared Jul 07, 1993
INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
K921751 · LJS
Strato Medical Corp.
General Hospital · 450d
Cleared Jul 07, 1993
4 SURE TM SUCTION CATHETERS & KITS
K921851 · BSY
Boston Pacific Medical, Inc.
Anesthesiology · 446d
Cleared Jul 07, 1993
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
K924212 · GBZ
Stryker Corp.
General & Plastic Surgery · 321d
Cleared Jul 07, 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · JOH
Customed, Inc.
Anesthesiology · 286d
Cleared Jul 07, 1993
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
K926143 · GBZ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 212d
Cleared Jul 06, 1993
BARRIER SAF-TE HYDROGEL DRAPE
K922918 · KKX
Johnson & Johnson International
General Hospital · 383d
Cleared Jul 06, 1993
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · GCT
Medical Devices, Inc.
Gastroenterology & Urology · 280d
Cleared Jul 06, 1993
HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES
K925363 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 257d
Cleared Jul 06, 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · GKZ
Coulter Corp.
Hematology · 214d
Cleared Jul 06, 1993
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
K930160 · GDM
Symbiosis Corp.
General & Plastic Surgery · 174d
Cleared Jul 06, 1993
ANAGO SPINAL ANESTHESIA TRAY
K930161 · CAZ
Anago, Inc.
Anesthesiology · 174d
Cleared Jul 06, 1993
MARCO INTERNATIONAL STAND
K930440 · HMF
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jul 06, 1993
MARCO STANDARD LENSMETERS 101,201
K930441 · HLM
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jul 06, 1993
MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE
K930443 · HOS
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jul 06, 1993
MARCO TRIAL SETS
K930446 · HPC
Marco Ophthalmic, Inc.
Ophthalmic · 161d