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"
4609–4632 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 09, 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 302d
Cleared Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489 · LCX
Healthcheck Corp.
Chemistry · 133d
Cleared Mar 03, 1989
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · KRA
Baxter Healthcare Corp
Cardiovascular · 66d
Cleared Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 88d
Cleared Mar 01, 1989
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
K885339 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · GGP
Baxter Healthcare Corp
Hematology · 34d
Cleared Feb 17, 1989
OXYGENATION CATHETER
K881881 · BTM
Ventech Healthcare Corp., Inc.
Anesthesiology · 289d
Cleared Feb 08, 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 16d
Cleared Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 198d
Cleared Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · GGN
Baxter Healthcare Corp
Hematology · 71d
Cleared Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · GGP
Baxter Healthcare Corp
Hematology · 72d
Cleared Jan 31, 1989
H-3000 OXYGEN CONCENTRATOR
K890150 · CAW
Healthdyne, Inc.
Anesthesiology · 18d
Cleared Jan 31, 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 92d
Cleared Jan 30, 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Jan 25, 1989
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · DRS
Baxter Healthcare Corp
Cardiovascular · 29d
Cleared Jan 25, 1989
BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
K885019 · FRG
Bemis Health Care
General Hospital · 57d
Cleared Jan 24, 1989
BAXTER STERILE TOWEL
K890006 · KKX
Healthmed Corp.
General Hospital · 21d
Cleared Jan 24, 1989
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · KFM
3M Health Care, Sarns
Cardiovascular · 78d
Cleared Jan 09, 1989
GAUZE BANDAGE 4 X 6 YDS.
K884335 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Jan 09, 1989
GAUZE BANDAGE 1 X 6 YDS.
K884334 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Jan 09, 1989
GAUZE BANDAGE 2 X 6 YDS.
K884333 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 69d