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"
4465–4488 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 27, 1990
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
K900129 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 55d
Cleared Feb 16, 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · FYA
Baxter Healthcare Corp
General Hospital · 65d
Cleared Feb 16, 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · KNK
Baxter Healthcare Corp
Chemistry · 93d
Cleared Feb 15, 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · KGO
Baxter Healthcare Corp
General Hospital · 49d
Cleared Feb 09, 1990
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
K900487 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 17d
Cleared Feb 09, 1990
MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
K900055 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 09, 1990
MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER
K900043 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · DYG
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Feb 08, 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · DIF
Baxter Healthcare Corp
Toxicology · 308d
Cleared Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635 · GNW
Baxter Healthcare Corp
Microbiology · 72d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642 · JJY
Baxter Healthcare Corp
Toxicology · 296d
Cleared Feb 02, 1990
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · FRN
Baxter Healthcare Corp
General Hospital · 329d
Cleared Feb 01, 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · KIR
Baxter Healthcare Corp
Pathology · 58d
Cleared Feb 01, 1990
DEVILBISS MODEL PV02 SERIES
K896457 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 80d
Cleared Jan 31, 1990
ARTERIOVENOUS FISTULA SETS
K900125 · FIE
Baxter Healthcare Corp
Gastroenterology & Urology · 22d
Cleared Jan 31, 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · DTN
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Jan 31, 1990
ANGIOSCOPY PUMP
K895074 · DQI
Baxter Healthcare Corp
General Hospital · 170d
Cleared Jan 30, 1990
MODIFIED ASSESS(R) PEAK FLOW METER
K896953 · BZH
Health Products, Inc.
Anesthesiology · 56d
Cleared Jan 29, 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 131d
Cleared Jan 29, 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 132d
Cleared Jan 22, 1990
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · CAI
Baxter Healthcare Corp
Anesthesiology · 77d
Cleared Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · HFM
Healthdyne, Inc.
Obstetrics & Gynecology · 230d
Cleared Jan 19, 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · KRA
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Jan 10, 1990
NOVA PILLOW
K895477 · IQK
Nova Health Systems, Inc.
Physical Medicine · 121d