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
111457–111480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1993
MOBILE CARE IV STAND
K932498 · FOX
Mobile Care, Inc.
General Hospital · 156d
Cleared Oct 27, 1993
ISI(R) HOOK SUTURES SCISSORS
K932698 · GCJ
Innovative Surgical, Inc.
General & Plastic Surgery · 146d
Cleared Oct 27, 1993
BARD PTFE VASCULAR GRAFT
K933204 · DSY
C.R. Bard, Inc.
Cardiovascular · 118d
Cleared Oct 27, 1993
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION...
K933319 · GCY
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 112d
Cleared Oct 27, 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR X-DEFICIENT PLASMA
K933441 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
STAGO FACTOR XI-DEFICIENT PLASMA
K933444 · GJT
American Bioproducts Co.
Hematology · 105d
Cleared Oct 27, 1993
BOOTY ENDOSCOPE WARMER
K933515 · GCI
T-Med, Inc.
General & Plastic Surgery · 99d
Cleared Oct 27, 1993
CAPNODIG
K933707 · CCK
Spegas Industries, Ltd.
Anesthesiology · 89d
Cleared Oct 27, 1993
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
K934172 · GEY
Acro-Poly, Inc.
General & Plastic Surgery · 61d
Cleared Oct 27, 1993
BECKMAN CX AMMONIA/ALCOHOL CONTROL
K934467 · DKC
Beckman-Diagnostic Systems Group
Toxicology · 47d
Cleared Oct 27, 1993
STAR BREATHING CIRCUITS
K934753 · BZO
Infrasonics Corp.
Anesthesiology · 23d
Cleared Oct 25, 1993
OTT INSUFFLATION FILTER TUBING
K920205 · HIF
Georgia Biomedical Research Group, Inc.
Obstetrics & Gynecology · 648d
Cleared Oct 25, 1993
STERI-CATH MDI
K923559 · CAF
Concord/Portex
Anesthesiology · 465d
Cleared Oct 25, 1993
FLEX-TECH BALLOON DILATOR
K926038 · KNQ
Cape Tech Medical Products
Gastroenterology & Urology · 328d
Cleared Oct 25, 1993
MODEL 9100 H.R. INFANT SCALE
K926174 · FRW
Acme Medical Scale Co.
General Hospital · 321d
Cleared Oct 25, 1993
CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY
K926252 · IYO
Endosonics Corp.
Radiology · 315d
Cleared Oct 25, 1993
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
K931542 · BZK
Newport Medical Instruments, Inc.
Anesthesiology · 210d
Cleared Oct 25, 1993
POWDER-FREE LATEX PATIENT EXAMINATION GLOVES
K931633 · LYY
Tomarc (M) Sdn Bhd
General Hospital · 206d
Cleared Oct 25, 1993
1500 SERIES REGULATOR
K932006 · CAN
Precision Medical, Inc.
Anesthesiology · 187d
Cleared Oct 25, 1993
PATHROMTIN
K932011 · GFO
Behring Diagnostics, Inc.
Hematology · 185d
Cleared Oct 25, 1993
FLYNNR GENESIS II A/C, A/O AND IDLH
K932170 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 174d
Cleared Oct 25, 1993
SAFESET RESERVOIR
K932188 · KRA
Abbott Laboratories
Cardiovascular · 172d