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
119665–119688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1991
RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR
K913621 · EAJ
Rinn Dental Products
Radiology · 45d
Cleared Sep 27, 1991
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 27, 1991
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
K914033 · JGY
Cholestech Corp.
Chemistry · 17d
Cleared Sep 27, 1991
LIFELINE(R) PERSONAL RESPONSE SYSTEM
K914103 · ILQ
Lifeline Systems, Inc.
Physical Medicine · 15d
Cleared Sep 27, 1991
ENDOSTAT
K914104 · GEX
Laserscope
General & Plastic Surgery · 14d
Cleared Sep 26, 1991
MEGA SPINAL ANESTHESIA KIT
K912322 · CAZ
Mega Medical, Inc.
Anesthesiology · 125d
Cleared Sep 25, 1991
CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO
K910027 · GEX
Biovision, Inc.
General & Plastic Surgery · 265d
Cleared Sep 25, 1991
COHERENT HOLMIUM:YAG SURGICAL LASER
K910037 · GEX
Coherent Medical Group
General & Plastic Surgery · 264d
Cleared Sep 25, 1991
EBNA STAT TEST KIT
K911473 · LLM
Whittaker Bioproducts, Inc.
Microbiology · 174d
Cleared Sep 25, 1991
IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003
K912229 · GEI
Dlp, Inc.
General & Plastic Surgery · 128d
Cleared Sep 25, 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · KLI
Technicon Instruments Corp.
Chemistry · 104d
Cleared Sep 25, 1991
J&S IRON REAGENTS
K912716 · JMO
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 25, 1991
J&S UIBC REAGENTS
K912717 · JMO
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 25, 1991
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
K912839 · FBW
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Sep 25, 1991
DESERT SHIELD SUNGLASSES
K912863 · HQY
Command Marketing Corp.
Ophthalmic · 89d
Cleared Sep 25, 1991
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · DTP
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 25, 1991
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · DTZ
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 25, 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Sep 25, 1991
IV HOUSE
K912942 · KMK
Progressive Iv'S, Inc.
General Hospital · 84d
Cleared Sep 25, 1991
ELEC SURG INSTR FOR LOPPROSCOPE CHOLECYSTECYOMY
K912968 · GEI
Paden Foudry , Ltd.
General & Plastic Surgery · 79d
Cleared Sep 25, 1991
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · FRO
Hollister, Inc.
General & Plastic Surgery · 78d
Cleared Sep 25, 1991
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
K913079 · KQX
Lucas Sensing Systems, Inc.
Neurology · 76d
Cleared Sep 25, 1991
KODAK EKTACHEM DT SLIDES (LIPASE)
K913196 · CHT
Eastman Kodak Company
Chemistry · 69d