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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
3961–3984 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 31, 1994
TONSIL SPONGES
K935882 · GDY
Mcneil Healthcare, Inc.
General & Plastic Surgery · 53d
Cleared Jan 31, 1994
SPECIALTY SPONGES
K935881 · GDY
Mcneil Healthcare, Inc.
General & Plastic Surgery · 53d
Cleared Jan 31, 1994
AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE
K935762 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 66d
Cleared Jan 26, 1994
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K936076 · JEQ
Ohio Health Care Products, Inc.
Dental · 37d
Cleared Jan 26, 1994
DISPOSE-A-SHEET
K933636 · KME
Belmac Healthcare Corp.
General Hospital · 183d
Cleared Jan 26, 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · DSY
Baxter Healthcare Corp
Cardiovascular · 184d
Cleared Jan 25, 1994
ENDOSCOPIC NEEDLE DRIVER
K933725 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 176d
Cleared Jan 24, 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · DYG
Baxter Healthcare Corp
Cardiovascular · 112d
Cleared Jan 21, 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
K935601 · FPA
Puritas Health Care, Inc.
General Hospital · 63d
Cleared Jan 14, 1994
READY CUT GAUZE GAUZE BOLTS
K935941 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
GAUZE SPONGE
K935940 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
GAUZE FLUFF
K935939 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS
K935938 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
POST OP SPONGE
K935937 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
CONFORMING ROLL
K935936 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BURN GAUZE PADS
K935935 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
CUSTOM BURN DRESSING
K935933 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BURN COMPRESS
K935932 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
NON-WOVEN SPONGE
K935931 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
TUBE, INHALER OXYGEN
K935582 · BZO
Puritas Health Care, Inc.
Anesthesiology · 57d
Cleared Jan 14, 1994
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
K935553 · BSY
Puritas Health Care, Inc.
Anesthesiology · 58d
Cleared Jan 13, 1994
SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
K935942 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 31d
Cleared Jan 07, 1994
PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES)
K934133 · LYY
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 142d
Cleared Jan 07, 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307 · KIJ
3M Health Care, Ltd.
Orthopedic · 241d