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
111601–111624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1993
HI BAND
K934452 · ESD
Argosy Electronics
Ear, Nose, Throat · 33d
Cleared Oct 12, 1993
P/METER
K921377 · DPW
Zertl Medical, Inc.
Radiology · 567d
Cleared Oct 12, 1993
ACCULYTE CHEMILUMINESCENCE ANALYZER
K921536 · JJQ
Laboratory Technologies, Inc.
Chemistry · 580d
Cleared Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
K921977 · LRG
Baxter Healthcare Corp
Microbiology · 539d
Cleared Oct 12, 1993
IVAC NEEDLELESS INJECTION VALVE
K922115 · FPA
Y
General Hospital · 525d
Cleared Oct 12, 1993
ISOLATION GOWNS
K922442 · FYC
Pfb Inter-Apparel Corp.
General Hospital · 508d
Cleared Oct 12, 1993
DANEK TISSUE CUTTING AND REMOVAL SYSTEM
K922486 · HRX
Sofamor Danek Mfg., Inc.
Orthopedic · 503d
Cleared Oct 12, 1993
ENDOPATH EP DISPOSABLE TROCAR
K922608 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 497d
Cleared Oct 12, 1993
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431 · IRO
Conair Corp.
Physical Medicine · 406d
Cleared Oct 12, 1993
BODY SOOTHER
K924518 · ISA
Conair Corp.
Physical Medicine · 403d
Cleared Oct 12, 1993
BODYTHERM
K924519 · IRO
Conair Corp.
Physical Medicine · 403d
Cleared Oct 12, 1993
HEALTH ESSENTIALS MAXI MASSAGER
K924581 · IRO
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582 · IRO
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583 · IRO
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584 · IRO
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
MOIST HEAT PAD
K924799 · IRT
Conair Corp.
Physical Medicine · 383d
Cleared Oct 12, 1993
MOSIST HEAT PAD WITH AUTOMATIC OFF
K924800 · IRT
Conair Corp.
Physical Medicine · 383d
Cleared Oct 12, 1993
DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET
K924837 · LDQ
Associated Ent., Inc.
General & Plastic Surgery · 382d
Cleared Oct 12, 1993
KING SIZE HEAT PAD
K924885 · IRT
Conair Corp.
Physical Medicine · 379d
Cleared Oct 12, 1993
NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS
K925487 · DZE
Nobelpharma USA, Inc.
Dental · 347d
Cleared Oct 12, 1993
MERIDIAN EBV-EA TEST KIT
K925688 · LSE
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Oct 12, 1993
MERIDIAN EBV-IGG TEST KIT
K925689 · MCD
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Oct 12, 1993
MERIDIAN EBNA TEST KIT
K925690 · LLM
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Oct 12, 1993
BRANEMARK SYSTEM SELF-TAPPING FIXTURE
K925762 · DZE
Nobelpharma USA, Inc.
Dental · 333d