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
111793–111816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · CGN
Bio-Rad
Chemistry · 70d
Cleared Oct 01, 1993
IL TEST CARBAMAZEPHINE
K933684 · KLT
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Oct 01, 1993
MARCHON/MARCOLIN EYEGLASSES
K933733 · HQZ
Marchon Eyewear, Inc.
Ophthalmic · 60d
Cleared Oct 01, 1993
SNIFF POSITION PILLOW
K934235 · CCX
American Medical Development, Inc.
Anesthesiology · 32d
Cleared Sep 30, 1993
MEADOX SURGIMED BALLOON CATHETER
K923947 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 421d
Cleared Sep 30, 1993
BODY TRAINER
K924520 · ISA
Conair Corp.
Physical Medicine · 391d
Cleared Sep 30, 1993
SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A
K925434 · ITX
Kretz Technik
Radiology · 337d
Cleared Sep 30, 1993
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · LJC
Syva Co.
Microbiology · 302d
Cleared Sep 30, 1993
IV COMFORT PAD
K930663 · KMK
D.J. Scott Mfg., Inc.
General Hospital · 233d
Cleared Sep 30, 1993
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · BTI
Devilbiss Health Care, Inc.
Anesthesiology · 216d
Cleared Sep 30, 1993
WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER
K931086 · IRO
Windmere Corp.
Physical Medicine · 211d
Cleared Sep 30, 1993
TECHLAB 1-HOUR TOX-A-TEST
K931129 · LLH
Techlab, Inc.
Microbiology · 209d
Cleared Sep 30, 1993
PERI-COMFORT(TM) SEATING CUSHION
K932396 · LRL
Chi'Am Intl.
Gastroenterology & Urology · 135d
Cleared Sep 30, 1993
STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT
K932625 · ILK
Stair Assist Corp.
Physical Medicine · 121d
Cleared Sep 30, 1993
TRACE TRANSFERRIN REAGENT
K932713 · DDQ
Trace Scientific , Ltd.
Hematology · 118d
Cleared Sep 30, 1993
RECLINING GERI CHAIRS W/CASTERS & LAP TRAY
K933000 · INM
Winco, Inc.
Physical Medicine · 104d
Cleared Sep 30, 1993
TRAVEL EASE
K933406 · IOR
Merits Health Products., Inc.
Physical Medicine · 80d
Cleared Sep 30, 1993
POWERMATIC EXAMINATION TABLE
K933577 · INQ
Medical Device Inspection Co., Inc.
Physical Medicine · 70d
Cleared Sep 30, 1993
MICROLITE WHEELCHAIR
K933919 · IOR
Morgan Technology, Inc.
Physical Medicine · 51d
Cleared Sep 29, 1993
NIKKISO NK PUMP
K920077 · DWD
International Medical Products, Inc.
Cardiovascular · 630d
Cleared Sep 29, 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · JOJ
American Sterilizer Co.
General Hospital · 499d
Cleared Sep 29, 1993
COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS
K923575 · GEX
Coherent Medical Group
General & Plastic Surgery · 436d
Cleared Sep 29, 1993
VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS
K925094 · EHD
Gendex Corp.
Radiology · 357d
Cleared Sep 29, 1993
VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE
K925647 · GEI
Valleylab, Inc.
General & Plastic Surgery · 324d