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
99433–99456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1996
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · FNM
Span-America Medical Systems, Inc.
General Hospital · 86d
Cleared Jan 11, 1996
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
K954819 · DZE
Lifecore Biomedical, Inc.
Dental · 83d
Cleared Jan 11, 1996
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · DZE
Lifecore Biomedical, Inc.
Dental · 80d
Cleared Jan 11, 1996
SOFT VENOUS RESERVOIR
K955046 · DTN
Gish Biomedical, Inc.
Cardiovascular · 69d
Cleared Jan 11, 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048 · DZE
The Implant Center of the Palm Beaches
Dental · 69d
Cleared Jan 11, 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · HQY
Diamond Mark International Co., Ltd.
Ophthalmic · 35d
Cleared Jan 05, 1996
HOLOPSY SYSTEM
K951999 · IYO
Neovision Corp.
Radiology · 252d
Cleared Jan 05, 1996
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
K952569 · HQR
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
K952581 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
K952585 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
K953077 · CDF
Beckman Instruments, Inc.
Chemistry · 189d
Cleared Jan 05, 1996
TITANIUM HEMOSTATIC CLIP
K953258 · FZP
Intramed Laboratories, Inc.
General & Plastic Surgery · 177d
Cleared Jan 05, 1996
BOUFFANT CAP
K953878 · FYF
American Threshold Industries, Inc.
General & Plastic Surgery · 142d
Cleared Jan 05, 1996
SURGEON'S CAP
K953879 · FYF
American Threshold Industries, Inc.
General & Plastic Surgery · 142d
Cleared Jan 05, 1996
COMPU-BLEND EPILATOR
K954031 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 130d
Cleared Jan 05, 1996
SIEMENS VIRTURAL WEDGE
K954248 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Jan 05, 1996
CLARK TUT IMAGE PROCESSING SYSTEM
K954589 · LLZ
Clark Research and Development, Inc.
Radiology · 94d
Cleared Jan 05, 1996
PRO VISION
K954678 · LLZ
Algotec Systems, Ltd.
Radiology · 87d
Cleared Jan 05, 1996
ACRYSTEEL BLOCKING TRAY
K954705 · IYE
Medtec, Inc.
Radiology · 85d
Cleared Jan 05, 1996
SEMINAL FLUID COLLECTION KIT II
K954791 · HIS
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 79d
Cleared Jan 05, 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839 · CIT
Sigma Diagnostics, Inc.
Chemistry · 77d
Cleared Jan 05, 1996
2.0 X 6MM SCREW
K955140 · DZL
Brasseler USA I, L.P.
Dental · 53d
Cleared Jan 05, 1996
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · KCY
Smith & Nephew Richards, Inc.
General & Plastic Surgery · 31d
Cleared Jan 04, 1996
CAL-FORM DENTAL IMPLANTS
K933646 · DZE
Cal-Form, Inc.
Dental · 891d