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
157465–157488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1983
PNEUMATIC ANTERIOR CHAMBER MAINTAINER
K830143
Diversatronics, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1983
ANESTHESIA APPARATUS PH-35
K830159 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
ANESTHESIA APPARATUS #FO 20S
K830160 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
ANESTHESIA APATATUS #D-25
K830161 · BSZ
W.E. Leder Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 09, 1983
UNIV. KNEE, CUTTING INSTRUMENTATION
K830185
Intermedics Orthopedics
General & Plastic Surgery · 49d
Cleared Mar 09, 1983
CAT 3040
K830193 · KPE
Burron Medical Products, Inc.
General Hospital · 48d
Cleared Mar 09, 1983
AFT SYSTEM III
K830214 · DHN
Calbiochem-Behring Corp.
Immunology · 44d
Cleared Mar 09, 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · HLJ
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Mar 09, 1983
DORC COMPACT MICRO SURGICAL SYSTEM
K830216 · HQE
Jedmed Instrument Co.
Ophthalmic · 44d
Cleared Mar 09, 1983
SHERIDAN/ESOPHAGEAL STETHOSCOPE
K830218 · BZW
Sheridan Catheter Corp.
Anesthesiology · 44d
Cleared Mar 09, 1983
ROENTGENOGRAPHY SET
K830229 · DGD
Mallinckrodt Critical Care
Immunology · 44d
Cleared Mar 09, 1983
TRACTION ACCESSORIES
K830244 · HST
Warm & Form, Orthopedic Materials
Neurology · 43d
Cleared Mar 09, 1983
HEAD HALTER
K830245 · ILZ
Warm & Form, Orthopedic Materials
Physical Medicine · 43d
Cleared Mar 09, 1983
OSTEOTOMY BONE STAPLE
K830255 · HXJ
Techmedica, Inc.
Orthopedic · 43d
Cleared Mar 09, 1983
REGNELL HYDRAULIC FEMORAL PROTHESIS
K830285 · KFX
Besco Financial Service
Physical Medicine · 41d
Cleared Mar 09, 1983
ZIMMER SKIN PROTECTOR
K830287 · GAD
Zimmer, Inc.
General & Plastic Surgery · 41d
Cleared Mar 09, 1983
DORC CONTACT/PHOTO DERATOSCOPE
K830290 · HJA
Jedmed Instrument Co.
Ophthalmic · 41d
Cleared Mar 09, 1983
DORC CORNEAL PUNCH BLOCK
K830335 · HNJ
Jedmed Instrument Co.
Ophthalmic · 36d
Cleared Mar 09, 1983
DORC INTRAOCULAR ELECTROMAGNET
K830336 · HPO
Jedmed Instrument Co.
Ophthalmic · 36d
Cleared Mar 09, 1983
VINYL EXTRICATION COLLAR
K830348 · IQK
Deip Enterprises, Inc.
Physical Medicine · 34d
Cleared Mar 09, 1983
SAC-RO-FORM INSERT & BINDER
K830349
Deip Enterprises, Inc.
Physical Medicine · 34d
Cleared Mar 09, 1983
CERVICAL PILLOW
K830350 · IQK
Deip Enterprises, Inc.
Physical Medicine · 34d
Cleared Mar 09, 1983
DISPOSABLE EXTRICATION COLLAR
K830351 · IQK
Deip Enterprises, Inc.
Physical Medicine · 34d
Cleared Mar 09, 1983
TITANIUM M.E. MULLER TYPE TOTAL HIP
K830356 · JDI
Boehringer Mannheim Corp.
Orthopedic · 34d