FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72361–72384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2003
DIOLASE 980 D LASER SYSTEM
K023547 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 176d
Cleared Apr 15, 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 15, 2003
GROMAN PREPMASTER
K030292 · KOJ
Groman, Inc.
Dental · 77d
Cleared Apr 15, 2003
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS...
K030385 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 69d
Cleared Apr 15, 2003
BIOUNIVERSAL PKF
K030435 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 15, 2003
BIO UNIVERSAL
K030436 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 14, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 193d
Cleared Apr 14, 2003
L1 SYSTEM
K024170 · FMK
Pelikan Technologies, Inc.
General & Plastic Surgery · 117d
Cleared Apr 14, 2003
VINCO BRAND ACUPUNCTURE NEEDLE
K024207 · MQX
Helio Medical Supplies, Inc.
General Hospital · 115d
Cleared Apr 14, 2003
URINE MONOVETTE BORIC ACID
K024237 · JSM
Sarstedt, Inc.
Microbiology · 112d
Cleared Apr 14, 2003
POLRIS LV
K030186 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d
Cleared Apr 14, 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · GEI
Leonhard Lang GmbH
General & Plastic Surgery · 70d
Cleared Apr 14, 2003
CERACAST-V
K030416 · EJH
Mountain Medico, Inc.
Dental · 63d
Cleared Apr 14, 2003
LINA-BAG, MODELS LB-60, LB-100
K030422 · GCJ
Lina Medical Cml Aps
General & Plastic Surgery · 63d
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · MVO
Phamatech
Toxicology · 62d
Cleared Apr 14, 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · EGS
Pac-Dent International (Suzhou), Ltd.
Dental · 48d
Cleared Apr 14, 2003
PASCO MIC AND MIC/ID PANELS
K030620 · LTT
Pasco Laboratories, Inc.
Microbiology · 46d
Cleared Apr 14, 2003
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · CEN
Uridynamics, Inc.
Chemistry · 45d
Cleared Apr 14, 2003
PROTEC-TOP, STERIDENT, BENTO
K031022 · FRG
Ronpak, Inc.
General Hospital · 14d
Cleared Apr 11, 2003
GOLDWAY PATIENT MONITOR, MODEL # UT4000F
K021154 · MWI
Goldway Us, Inc.
Cardiovascular · 366d
Cleared Apr 11, 2003
SK MED M201 MIXER
K022864 · BZR
Sk Med
Anesthesiology · 226d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 11, 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE...
K030270 · LJS
Medcomp
General Hospital · 74d
Cleared Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN...
K030320 · JIS
Wako Chemicals USA, Inc.
Chemistry · 71d