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
110665–110688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1994
AUTOVAC CLOSED WOUND SUCTION SYSTEM
K930615 · GCY
Boehringer Laboratories
General & Plastic Surgery · 382d
Cleared Feb 22, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K930788 · LZO
Smith & Nephew Richards, Inc.
Orthopedic · 371d
Cleared Feb 22, 1994
PCA(R) SOLID BACK ACETABULA SHELL
K930833 · JDL
Howmedica Corp.
Orthopedic · 370d
Cleared Feb 22, 1994
COOL-AID
K931203 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 350d
Cleared Feb 22, 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · JDQ
Acu Med, Inc.
Orthopedic · 348d
Cleared Feb 22, 1994
P4000 PHACOEMULSIFIER
K931354 · HQC
American Optical Corp.
Ophthalmic · 342d
Cleared Feb 22, 1994
AORP4000 REUSABLE PAK
K931358 · HQC
American Optical Corp.
Ophthalmic · 342d
Cleared Feb 22, 1994
SURGICAL PATCH SPREADER
K931425 · GCJ
General Surgical Innovations
General & Plastic Surgery · 337d
Cleared Feb 22, 1994
CAREJECT DISPOSABLE SYRINGE AND NEEDLE
K931472 · FMF
Carewell Mediproducts, Ltd.
General Hospital · 335d
Cleared Feb 22, 1994
SUNGLASSES
K931497 · HQY
Wain Lin Trading Corp.
Ophthalmic · 323d
Cleared Feb 22, 1994
SUNGLASSES
K931512 · HQY
Alpina U.S.A. Eyewear, Inc.
Ophthalmic · 333d
Cleared Feb 22, 1994
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
K931578 · JEC
Applied Osteo Systems, Inc.
Orthopedic · 329d
Cleared Feb 22, 1994
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · FTD
Medline Industries, Inc.
General & Plastic Surgery · 322d
Cleared Feb 22, 1994
I.V. START KIT
K931729 · FOZ
Carapace, Inc.
General Hospital · 321d
Cleared Feb 22, 1994
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734 · HWE
Intermedics Orthopedics
Orthopedic · 321d
Cleared Feb 22, 1994
SUNDASH
K932483 · LEJ
Sun Ind., Inc.
General & Plastic Surgery · 274d
Cleared Feb 22, 1994
MULTI-PORT MANIFOLD
K932512 · FMG
Baxter Healthcare Corp
General Hospital · 273d
Cleared Feb 22, 1994
CABOT MEDICAL IRRIGATION FLUID WARMER SETS
K932538 · LHC
Cabot Medical Corp.
General Hospital · 272d
Cleared Feb 22, 1994
ELECTROSURGIAL INSTRUMENTS
K932654 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 265d
Cleared Feb 22, 1994
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
K932853 · JEL
Applied Osteo Systems, Inc.
Ear, Nose, Throat · 257d
Cleared Feb 22, 1994
EZ GRIP DISPOSABLE ELECTRODES
K932854 · GZJ
Advanced Adhesives
Neurology · 257d
Cleared Feb 22, 1994
THE MODULAR NAIL
K933027 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 245d
Cleared Feb 22, 1994
ELECTROCAUTERY SYSTEM MODEL 1980
K933079 · HQP
Pmt Corp.
Ophthalmic · 244d
Cleared Feb 22, 1994
ACU-SUTURE KIT
K933137 · LRO
Acuderm, Inc.
General & Plastic Surgery · 239d