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
170065–170088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1978
TABLE, EXAMINING-TWO EIGHTY
K782064 · ETF
Amsco Co.
Ear, Nose, Throat · 15d
Cleared Dec 28, 1978
LASER, PHOTOCOAGULATION
K782065 · HQF
Cavitron Corp.
Ophthalmic · 15d
Cleared Dec 27, 1978
SPONGE SYSTEM, ROSERING CONTAIN-COUNT
K782120
Medline Industries, Inc.
General & Plastic Surgery
Cleared Dec 27, 1978
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
K782146 · DXY
Arco Medical Products Co.
Cardiovascular
Cleared Dec 26, 1978
MONITOR, SENSOMATIII OXYGEN
K781910 · KLK
Biochem International, Inc.
Anesthesiology · 42d
Cleared Dec 26, 1978
VALVE, AMBU PEEP
K782152 · BYE
Narco Air-Shields
Anesthesiology
Cleared Dec 22, 1978
LITHICRON F PROGRAMMABLE PULSE GEN
K780430 · DXY
Medcor, Inc.
Cardiovascular · 280d
Cleared Dec 22, 1978
MICROLITH A MODEL 703
K782022 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 22, 1978
MICROLITH A MODEL 803
K782023 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 22, 1978
MAXI CAMERA 400T
K782029 · IYX
General Electric Co.
Radiology · 17d
Cleared Dec 22, 1978
ELECTRODE LEAD MODEL 030-198
K782097 · DTD
Telectronics, Inc.
Cardiovascular · 4d
Cleared Dec 21, 1978
PACING LEAD MODEL BUS 860, BUS 890
K781624 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 92d
Cleared Dec 21, 1978
PULSTRON MODEL 100
K781835 · DXY
Micro-Rel
Cardiovascular · 52d
Cleared Dec 21, 1978
VENTILATOR, INFANT MODEL 100
K781926 · CBK
Healthdyne, Inc.
Anesthesiology · 43d
Cleared Dec 21, 1978
TRANSMITTER, TR-1 ECG
K782059 · DXH
Burdick Corp.
Cardiovascular · 14d
Cleared Dec 21, 1978
VENTILATOR, MODEL AVA-1, ADULT
K782074 · CBK
Rule Medical Instruments, Inc.
Anesthesiology · 8d
Cleared Dec 20, 1978
CORTRAL I
K780527 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 261d
Cleared Dec 20, 1978
HEMODIALYZER, MODEL RP610, RP AN 69
K781464 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 117d
Cleared Dec 20, 1978
API ZYM
K781567 · JTO
Analytical Products, Inc.
Microbiology · 97d
Cleared Dec 20, 1978
UROTRON
K781632 · JJQ
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Dec 20, 1978
RUBINDEX*DIRECT SYSTEM
K781638 · GOK
Ortho Diagnostics, Inc.
Immunology · 90d
Cleared Dec 20, 1978
SURGICAL GOWNS & DRAPES
K781682 · FYA
Kimberly-Clark Corp.
General Hospital · 79d
Cleared Dec 20, 1978
LINER, CAVITY CALCIUM HYDROXIDE
K781688 · EJK
Kerr Corporation (Danbury)
Dental · 77d
Cleared Dec 20, 1978
CHEMSTRIP CONTROL
K781691 · JJW
Boehringer Mannheim Corp.
Chemistry · 77d