FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75985–76008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 22d
Cleared Apr 16, 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Apr 16, 2002
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · FXX
Primeline Medical Products, Inc.
General Hospital · 13d
Cleared Apr 15, 2002
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
K003916 · IMB
Scandia Manufacturing , Ltd.
Physical Medicine · 482d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · KWP
United States Surgical, A Division of...
Orthopedic · 90d
Cleared Apr 15, 2002
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
K020145 · LPH
Orthopaedic Innovations, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
SERRALNYL
K020146 · GAR
Serral, S.A. DE C.V.
General & Plastic Surgery · 89d
Cleared Apr 15, 2002
CONSENSUS ACETABLAR SHELL, TI COATED
K020153 · LPH
Hayes Medical, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
L.A.M. IPM WOUND GEL
K020325 · MGQ
L.A.M. Pharmaceutical, Corp.
General & Plastic Surgery · 74d
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435 · KKX
Applied Medical Resources Corp.
General Hospital · 66d
Cleared Apr 15, 2002
CARESIDE TRGLYCERIDE
K020488 · CDT
Careside, Inc.
Chemistry · 61d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517 · MNI
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · GGC
Bio-Rad
Hematology · 28d
Cleared Apr 15, 2002
NBX - NON-BRIDGING EXTERNAL FIXATOR
K020905 · LXT
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Apr 12, 2002
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
K011903 · DQK
Vivometrics, Inc.
Cardiovascular · 298d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
K012651 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10,...
K012654 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
K012657 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002
K020135 · GEI
Conmedcorp
General & Plastic Surgery · 87d
Cleared Apr 12, 2002
CONMED SYSTEM 5000 ESU
K020186 · GEI
Conmedcorp
General & Plastic Surgery · 84d
Cleared Apr 12, 2002
RPI SKIN OR AIR TEMPERATURE PROBE
K020219 · FMT
Replacement Parts Industries, Inc.
General Hospital · 80d
Cleared Apr 12, 2002
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · NEU
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 74d
Cleared Apr 12, 2002
DENTITION INTEGRATING MATERIAL
K020287 · EBC
Pulpdent Corporation
Dental · 74d