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
171601–171624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1978
MINYSTAG MN-1
K780338 · DSF
Lkb Instruments, Inc.
Cardiovascular · 14d
Cleared Mar 15, 1978
PAVLIK HARNESS
K780375 · IOZ
Biomet, Inc.
Physical Medicine · 7d
Cleared Mar 15, 1978
IMPROVED DYCAL
K780384 · EJK
L.D. Caulk Co.
Dental · 6d
Cleared Mar 14, 1978
TOILET SAFETY RAIL
K772275 · LDQ
Med Fusion Systems, Inc.
General & Plastic Surgery · 95d
Cleared Mar 14, 1978
RAISED TOILET SEAT
K772276 · LDQ
Med Fusion Systems, Inc.
General & Plastic Surgery · 95d
Cleared Mar 14, 1978
DENTAL ALLOY
K780090 · EJH
Krupp International, Inc.
Dental · 60d
Cleared Mar 14, 1978
LIFESAVER, MANUAL #5160
K780216 · BTM
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 32d
Cleared Mar 14, 1978
TEMP. SENSOR W/22MM FITTINGS
K780260 · KPD
Bd Becton Dickinson Vacutainer...
General Hospital · 27d
Cleared Mar 14, 1978
ELECTROSURGICAL UNIT
K780293 · HAM
Ritter Co.
General & Plastic Surgery · 21d
Cleared Mar 14, 1978
HITACHI TECH-MOBLE DHC-121
K780313 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 18d
Cleared Mar 14, 1978
ORBITOME-UG
K780319 · IZF
Philips Medical Systems (Cleveland),...
Radiology · 18d
Cleared Mar 14, 1978
ANALYZER, PULMONARY FUNCTION
K780322 · BZC
Hospal Medical Corp.
Anesthesiology · 15d
Cleared Mar 14, 1978
CAPNOMETER MODEL 47210A
K780324 · CCK
Hewlett-Packard Co.
Anesthesiology · 15d
Cleared Mar 14, 1978
GE CT/T 8800 SYSTEM
K780326 · JAK
General Electric Co.
Radiology · 15d
Cleared Mar 14, 1978
PULMONARY FUNCTION TESTER, COMPUTERIZED
K780328 · BZC
Warren E. Collins, Inc.
Anesthesiology · 15d
Cleared Mar 14, 1978
VAGINAL RETRACTOR
K780349 · HDL
Edward Weck, Inc.
Obstetrics & Gynecology · 11d
Cleared Mar 14, 1978
MODUMED MUGX
K780368 · JWM
Medtronic Vascular
Radiology · 7d
Cleared Mar 14, 1978
MODUMED MUGE
K780369 · JWM
Medtronic Vascular
Radiology · 7d
Cleared Mar 14, 1978
MINIDENTOFLEX NEW POLISHING SYSTEM
K780376 · EHL
Cavitron Corp.
Dental · 6d
Cleared Mar 14, 1978
PINIDENTOFLEX DENTAL POLISHER
K780377 · EHL
Cavitron Corp.
Dental · 6d
Cleared Mar 14, 1978
AUDIOMETER, PORTABLE, AIR CONDUCTION
K780382 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 4d
Cleared Mar 09, 1978
HODGE TUBE
K772282 · FEG
Mallinckrodt Critical Care
Gastroenterology & Urology · 87d
Cleared Mar 09, 1978
PATIENT ALERT MODEL 555
K772350 · DXH
Intermedics, Inc.
Cardiovascular · 76d
Cleared Mar 09, 1978
ANDERSON-NEIVERT OSTEOTOME
K772373 · KDG
Edward Weck, Inc.
General & Plastic Surgery · 72d