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
171073–171096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1978
CLINICAL ANALYZER SYSTEM
K780903 · JJQ
Bausch & Lomb, Inc.
Chemistry · 28d
Cleared Jun 28, 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
ADJUSTABLE DISPENSOR
K780912 · JQW
Oxford Laboratories, Inc.
Chemistry · 23d
Cleared Jun 28, 1978
SOFT LENS INSERTER
K780931 · KYE
Soft-Sert
Ophthalmic · 22d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRATE 200
K781005 · GWQ
Beckman Instruments, Inc.
Neurology · 9d
Cleared Jun 28, 1978
ISOTONIC DILUENT
K781008 · GIF
Mallinckrodt Critical Care
Hematology · 9d
Cleared Jun 28, 1978
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 28, 1978
HEARING AID
K781033 · ESD
Phonemics, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRACE 100
K781041 · GWQ
Beckman Instruments, Inc.
Neurology · 8d
Cleared Jun 27, 1978
ULTRASONIC IMAGER
K780876 · HEM
Air-Shields, Inc.
Radiology · 28d
Cleared Jun 27, 1978
X-RAY SYSTEM
K780963 · KPQ
General X-Ray, Inc.
Radiology · 15d
Cleared Jun 27, 1978
GAMMA CAMERA
K780969 · IYX
Machlett Laboratories, Inc.
Radiology · 15d
Cleared Jun 27, 1978
X-RAY FRAME HOLDER
K780999 · IZL
Great Eastern Lumber Co., Inc.
Radiology · 18d
Cleared Jun 22, 1978
URIC ACID REFERENCE SERA
K780447 · JIT
Macomb Chemical Co.
Chemistry · 94d
Cleared Jun 22, 1978
STIMULATOR MODEL 8021
K780539 · GWF
Life-Tech Instruments, Inc.
Neurology · 80d
Cleared Jun 22, 1978
DETECTOR, BUBBLE & FOAM
K780582 · FJF
Hospal Medical Corp.
Gastroenterology & Urology · 71d
Cleared Jun 22, 1978
MASK, SURGEONS
K780607 · FXX
Abco Dealers, Inc.
General Hospital · 73d
Cleared Jun 22, 1978
SINGLE PATIENT SYSTEMS
K780682 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 59d
Cleared Jun 22, 1978
AUTO SUTURE DISPOSABLE STAPLING INSTRU.
K780695 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 59d
Cleared Jun 22, 1978
ANTICONVULSANTS III CALIBRATOR KIT
K780733 · DKH
Vitek Systems, Inc.
Toxicology · 51d
Cleared Jun 22, 1978
ANTICONVULSANTS II CALIBRATOR KIT
K780734 · DIY
Vitek Systems, Inc.
Toxicology · 51d
Cleared Jun 22, 1978
PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
K780773 · JDG
Depuy, Inc.
Orthopedic · 49d