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
108697–108720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1994
ULTRALINE II STERILE DISPOSABLE FIBER
K933245 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 293d
Cleared Apr 21, 1994
ARTHROSCOPE, DISPOSABLE
K933576 · HRX
United States Surgical, A Division of...
Orthopedic · 272d
Cleared Apr 21, 1994
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · FIB
Millipore Corp.
Gastroenterology & Urology · 244d
Cleared Apr 21, 1994
OT IGG SORBENT
K934324 · DEW
Organon Teknika Corp.
Microbiology · 230d
Cleared Apr 21, 1994
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · DGC
Ciba Corning Diagnostics Corp.
Immunology · 209d
Cleared Apr 21, 1994
ENDOFLUSH SYSTEM 1.0, 2.O, 3.0
K935207 · GCJ
Specialty Medical Systems, Inc.
General & Plastic Surgery · 174d
Cleared Apr 21, 1994
A-DEC CASCADE 3072 WALLMOUNT
K935325 · EIA
A-Dec, Inc.
Dental · 167d
Cleared Apr 21, 1994
TAVA WIRE-DRIVER
K935367 · HSZ
Tava Surgical Instruments
Orthopedic · 168d
Cleared Apr 21, 1994
SPECIMEN TRANSPORT MEDIUM
K935618 · JSM
Biowhittaker Molecular Applications,...
Microbiology · 150d
Cleared Apr 21, 1994
QTEST(R) STREP
K935667 · GTY
Becton Dickinson Advanced Diagnostics
Microbiology · 146d
Cleared Apr 21, 1994
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT
K935756 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 146d
Cleared Apr 21, 1994
SURGIPUMP
K935763 · DQI
W.O.M. World of Medicine GmbH
General Hospital · 146d
Cleared Apr 21, 1994
SERIM PYLORITEK REAGENT STRIPS
K936034 · JTO
Serim Research Corp.
Microbiology · 127d
Cleared Apr 21, 1994
STRESS HANDLER
K936148 · LYG
Arocep Enterprises , Ltd.
Physical Medicine · 115d
Cleared Apr 21, 1994
Y-TYPE BLOOD ADMINISTRATION SET
K940074 · BRZ
Puritas Health Care, Inc.
General Hospital · 105d
Cleared Apr 21, 1994
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · JZG
Beckman Instruments, Inc.
Immunology · 86d
Cleared Apr 21, 1994
BODY RECHARGER
K940369 · ISA
Conair Corp.
Physical Medicine · 85d
Cleared Apr 21, 1994
TITANIUM BIPOLAR FORCEPS
K940466 · GEI
Radionics, Inc.
General & Plastic Surgery · 78d
Cleared Apr 21, 1994
MODEL 777 THERAPEUTIC MASSAGER
K940543 · ISA
Voyager Medical Corp.
Physical Medicine · 73d
Cleared Apr 21, 1994
SYNERMEDIR CAL I AND SYNERMED IR CAL II
K940571 · JIX
Synermed, Inc.
Chemistry · 72d
Cleared Apr 21, 1994
DUPAQUE SPONGE
K941217 · GDY
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 38d
Cleared Apr 20, 1994
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
K921456 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 754d
Cleared Apr 20, 1994
QUANTEC SPINAL MEASUEMENT SYSTEM
K923792 · LDK
Quantec Image Processing , Ltd.
Physical Medicine · 631d
Cleared Apr 20, 1994
RIM E.COLI 0157:H7 LATEX TEST
K933457 · GNA
Remel Co.
Microbiology · 280d