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
101161–101184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1995
UNIMAT PUMP
K953075 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Sep 01, 1995
QUANTA LITE IGA ACA (HRP)
K953366 · MID
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Sep 01, 1995
POLLUX OA/POLLUX 30A/POLLUX 70A
K953484 · HRX
Pollux Endoscopy, Inc.
Orthopedic · 38d
Cleared Sep 01, 1995
INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS
K953781 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 18d
Cleared Sep 01, 1995
GIP/MEDI-GLOBE ERCP CATHETERS
K953827 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 17d
Cleared Sep 01, 1995
MED-TECH LASER GAS MIXTURE
K953933 · GEX
Medical Technical Gases Inc..
General & Plastic Surgery · 14d
Cleared Aug 31, 1995
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4
K932571 · GWE
Tomey Corporation USA
Neurology · 826d
Cleared Aug 31, 1995
ROTACHROM HEPARIN TEST KIT
K943515 · KFF
American Bioproducts Co.
Hematology · 406d
Cleared Aug 31, 1995
ROTACHROM HBPM/LMWH TEST KIT
K943516 · KFF
American Bioproducts Co.
Hematology · 406d
Cleared Aug 31, 1995
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
K951950 · DTB
Pacesetter, Inc.
Cardiovascular · 127d
Cleared Aug 31, 1995
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
K952206 · DTB
Pacesetter, Inc.
Cardiovascular · 113d
Cleared Aug 31, 1995
OSCILFLATOR
K952566 · MAV
Surgical Technologies, Inc.
Cardiovascular · 90d
Cleared Aug 31, 1995
MEDICAL GRADE SILICONE BLOCK
K952732 · MIB
Bioplexus Corp.
General & Plastic Surgery · 77d
Cleared Aug 31, 1995
DUPONT LIPASE CALIBRATOR
K952815 · JIT
Dupont Medical Products
Chemistry · 72d
Cleared Aug 31, 1995
AMERIMED AS110
K953069 · FNM
Amerimed Systems L.C.
General Hospital · 62d
Cleared Aug 31, 1995
SYNERMED CALCIUM REAGENT KIT
K953395 · CJY
Synermed, Inc.
Chemistry · 44d
Cleared Aug 30, 1995
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
K935475 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 653d
Cleared Aug 30, 1995
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
K935554 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 651d
Cleared Aug 30, 1995
BONE MINERAL DENSITOMETER
K941362 · KGI
Hologic, Inc.
Radiology · 527d
Cleared Aug 30, 1995
HEALTH IMAGE INC. HI STAR
K944724 · LNH
Health Images, Inc.
Radiology · 339d
Cleared Aug 30, 1995
HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K950624 · DZE
Lifecore Biomedical, Inc.
Dental · 201d
Cleared Aug 30, 1995
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR,...
K952459 · GZB
Medtronic Vascular
Neurology · 96d
Cleared Aug 30, 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE &...
K952811 · JEY
Implant Innovations, Inc.
Dental · 72d
Cleared Aug 30, 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM)...
K952812 · JEY
Implant Innovations, Inc.
Dental · 72d