FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
104593–104616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1995
IVALON OPHTHALMIC SPONGE
K946016 · HOZ
Ivalon
Ophthalmic · 103d
Cleared Mar 22, 1995
CUSTOM OCULAR PROSTHESIS
K946226 · HQH
Frank Tanaka, Ocularist, Inc.
Ophthalmic · 90d
Cleared Mar 22, 1995
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K946227 · HQC
Storz Instrument Co.
Ophthalmic · 90d
Cleared Mar 22, 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · FWP
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 89d
Cleared Mar 22, 1995
INTEC EXTENDED EYE SHIELD WITH MASK
K946343 · FXX
Intec Industries, Inc.
General Hospital · 82d
Cleared Mar 22, 1995
MULTI-WASH
K950324 · LRJ
Multi-Wash Medical, Ltd.
General Hospital · 72d
Cleared Mar 22, 1995
COLDCIDE-10
K950516 · LRJ
Metrex Research Corp.
General Hospital · 44d
Cleared Mar 22, 1995
COLDCIDE-2
K950553 · LRJ
Metrex Research Corp.
General Hospital · 43d
Cleared Mar 22, 1995
SIGMA 8000 AND SIGMA 8002
K950766 · FRN
Sigma Intl. General Medical...
General Hospital · 33d
Cleared Mar 22, 1995
STREAK RETINOSCOPE RX-2
K950790 · HKL
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Mar 22, 1995
HALOGEN DIAGNOSTIC SET BX A - 12345
K950796 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Mar 22, 1995
SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
K950822 · LDH
Solopak Laboratories, Inc.
General Hospital · 28d
Cleared Mar 22, 1995
CHAMP INTERNATIONAL CORP.
K950922 · HQY
Champ International Corp.
Ophthalmic · 21d
Cleared Mar 22, 1995
ULTIMATES SILK GLIDE TAMPONS
K950928 · HIL
Playtime Products, Inc.
Obstetrics & Gynecology · 21d
Cleared Mar 22, 1995
TRACHE-TITE
K950930 · CBH
The Varner Group, Inc.
Anesthesiology · 21d
Cleared Mar 22, 1995
XCEL SLIT LAMP
K951054 · HJO
Leica, Inc.
Ophthalmic · 15d
Cleared Mar 22, 1995
SUNGLASSES
K951080 · HQY
Taiwan Georgia Corp.
Ophthalmic · 13d
Cleared Mar 22, 1995
CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE
K951082 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 13d
Cleared Mar 21, 1995
DENTOOL
K923780 · EFB
Dentool, Inc.
Dental · 966d
Cleared Mar 21, 1995
MEDICAL PROCEDURE TRAY, MODIFICATION
K930884 · LDQ
Enpak Medical Corp.
General & Plastic Surgery · 762d
Cleared Mar 21, 1995
LATEX (K82)
K931746 · DHB
Diagnostic Products Corp.
Immunology · 712d
Cleared Mar 21, 1995
PERCUPUMP II
K932055 · FIH
E-Z-Em, Inc.
Radiology · 692d
Cleared Mar 21, 1995
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
K932779 · HET
Birtcher Medical Systems, Inc.
Obstetrics & Gynecology · 651d
Cleared Mar 21, 1995
FEMROD AND FEMROD RECON INSERT
K935383 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 498d